<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03776812</url>
  </required_header>
  <id_info>
    <org_study_id>CORT125134-552</org_study_id>
    <nct_id>NCT03776812</nct_id>
  </id_info>
  <brief_title>Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer</brief_title>
  <official_title>A Phase 2, Randomized, Open-Label, 3-arm Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corcept Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corcept Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, open-label, randomized, 3-arm study to evaluate progression-free survival&#xD;
      (PFS) in patients with recurrent platinum-resistant ovarian, fallopian tube, or primary&#xD;
      peritoneal cancer treated with intermittent or continuous regimens of relacorilant in&#xD;
      combination with nab-paclitaxel compared with patients treated with nab-paclitaxel alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR). The goals of&#xD;
      this study are to evaluate the efficacy of relacorilant either administered daily&#xD;
      (continuous) or on the day prior, the day of, and the day after chemotherapy (intermittent)&#xD;
      in combination with nab-paclitaxel in the treatment of platinum-resistant ovarian, fallopian&#xD;
      tube, or primary peritoneal cancers compared with nab-paclitaxel alone. The safety,&#xD;
      pharmacokinetics (PK), and pharmacodynamic profile of relacorilant in combination with&#xD;
      nab-paclitaxel will also be assessed.&#xD;
&#xD;
      Eligible patients will be randomized 1:1:1 to one of the following three treatment arms.&#xD;
      Patient randomization will be stratified by treatment-free interval from most recent taxane&#xD;
      (relapsed within 6 months vs &gt;6 months) and presence of ascites (yes vs no).&#xD;
&#xD;
        -  Arm A (Continuous relacorilant): Relacorilant starting at 100mg, administered orally,&#xD;
           once daily every day in combination with nab-paclitaxel on Days 1, 8, and 15 of each&#xD;
           28-day cycle.&#xD;
&#xD;
        -  Arm B (Intermittent relacorilant): Relacorilant 150mg, administered orally, on the day&#xD;
           before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in&#xD;
           combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.&#xD;
&#xD;
        -  Arm C (Comparator): Nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.&#xD;
&#xD;
      Patients will remain on study treatment until reaching a protocol-defined event of disease&#xD;
      progression (PD), experiencing unmanageable toxicity, or until other treatment&#xD;
      discontinuation criteria are met. All patients will be followed for progression, subsequent&#xD;
      therapies and survival. Patients in Arm C who experience unequivocal PD per RECIST v1.1 will&#xD;
      be given the opportunity to receive relacorilant in combination with nab-paclitaxel after&#xD;
      discussion with the Medical Monitor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Time from randomization until the date first documented of progressive disease (PD) by RECIST v1.1 (as determined by the Investigator at the local site), or death due to any cause, whichever occurs first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Proportion of patients with measurable disease at baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1 (confirmation not required).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR)</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Time from when response (CR or PR) was first documented to first objectively documented PD or death (whichever occurs first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response according to Gynecological Cancer Intergroup criteria (GCIG)</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Overall response per Gynecological Cancer Intergroup criteria (GCIG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BoR)</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Best response recorded from the date of randomization until PD/recurrence (or death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) Rate</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Proportion of patients who have not progressed at 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS in patients who crossover to continuous treatment at time of PD</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Time from randomization until the earliest date of progressive disease (PD) by RECIST v1.1, as determined by the Investigator at the local site, or death from any cause, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate in patients who crossover to continuous treatment at time of PD</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Proportion of patients with measurable disease at baseline who attain confirmed complete response (CR) or partial response (PR) by RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response in patients who crossover to continuous treatment at time of PD</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Time from when response (CR or PR) was first documented to first objectively documented PD or death (whichever occurs first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response in patients who crossover to continuous treatment at time of PD</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Proportion of patients with measurable disease at baseline who attain CR or PR by RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Antigen (CA)-125 Response</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>CA-125 response will be assessed per GCIG criteria defined as &gt;/=50% reduction in CA-125 from a pre-treatment sample and maintained for &gt;/- 28 days in patients with a pre-treatment sample that is at least twice the upper limit of the reference range and within 2 weeks before starting the treatment. In addition, patients who have a CA-125 response and whose CA-125 level falls to within the reference range will be classified as CA-125 complete responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>Time from randomization to death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined Response according to RECIST v1.1 + GCIG criteria</measure>
    <time_frame>12 months from enrollment of last subject</time_frame>
    <description>To assess combined response by RECIST 1.1 with GCIG criteria</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">178</enrollment>
  <condition>Recurrent Ovarian Cancer</condition>
  <condition>Recurrent Fallopian Tube Carcinoma</condition>
  <condition>Recurrent Primary Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Continuous Relacorilant Dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with relacorilant, administered orally, once daily every day in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermittent Relacorilant Dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with relacorilant, administered orally, on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nab-paclitaxel Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Relacorilant, 100mg QD</intervention_name>
    <description>Relacorilant is supplied as capsules for oral dosing</description>
    <arm_group_label>Continuous Relacorilant Dosing</arm_group_label>
    <other_name>CORT125134</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel, 80mg/m^2</intervention_name>
    <description>Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle</description>
    <arm_group_label>Continuous Relacorilant Dosing</arm_group_label>
    <arm_group_label>Intermittent Relacorilant Dosing</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel, 100mg/m^2</intervention_name>
    <description>Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle</description>
    <arm_group_label>Nab-paclitaxel Comparator</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Relacorilant, 150mg QD</intervention_name>
    <description>Relacorilant is supplied as capsules for oral dosing</description>
    <arm_group_label>Intermittent Relacorilant Dosing</arm_group_label>
    <other_name>CORT125134</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated IRB/IEC-approved informed consent form (ICF) prior to study-specific&#xD;
             screening procedures.&#xD;
&#xD;
          -  Female patients aged ≥ 18 years old at time of consent.&#xD;
&#xD;
          -  Histologic diagnosis of high grade serous or endometrioid epithelial ovarian, primary&#xD;
             peritoneal, or fallopian tube cancer or ovarian carcinosarcoma. Clear cell, mucinous&#xD;
             and borderline histologic subtypes are excluded.&#xD;
&#xD;
          -  Received at least one line of therapy with evidence of cancer progression within 6&#xD;
             months after the last dose of platinum-based therapy (i.e., having a platinum-free&#xD;
             interval of &lt;6 months [platinum resistant]), or progressive disease during or&#xD;
             immediately after primary platinum-therapy, (i.e.platinum refractory). Patients with&#xD;
             primary platinum resistance (progression within 6 months of the last dose of&#xD;
             first-line platinum-containing chemotherapy) are considered eligible.&#xD;
&#xD;
        Notes: For the calculation of the platinum-free interval, cancer progression must be&#xD;
        defined by clear evidence of progression, such as radiographic progression per RECIST v1.1.&#xD;
        Calculating the platinum-free interval on the basis of increased CA-125 is not allowed.&#xD;
&#xD;
          -  Measurable or non-measurable disease by RECIST v1.1:&#xD;
&#xD;
          -  Previously irradiated lesions are not allowed as measurable disease, unless there is&#xD;
             documented evidence of progression in the lesions.&#xD;
&#xD;
          -  To be eligible with non-measurable disease, patients must have evaluable disease with&#xD;
             CA 125 at least twice the upper limit of reference range (of CA-125 ≥ 70 U/mL), along&#xD;
             with radiographically evaluable disease by CT/MRI.&#xD;
&#xD;
          -  Availability and consent to provide tumor tissue for biomarker assays (archival or&#xD;
             recent biopsy).&#xD;
&#xD;
          -  No more than 4 prior chemotherapeutic or myelosuppressive regimens (not including&#xD;
             maintenance therapy such as single-agent bevacizumab or poly (ADP-ribose) polymerase&#xD;
             [PARP] inhibitor). Patients with platinum-refractory cancer cannot have had more than&#xD;
             2 prior lines of treatment for refractory disease.&#xD;
&#xD;
          -  Appropriate to treat with nab-paclitaxel, in the opinion of the Investigator.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.&#xD;
&#xD;
          -  Adequate organ and bone marrow function meeting the following criteria at the&#xD;
             Screening Visit:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3.&#xD;
&#xD;
               -  Platelet count ≥ 100,000/mm3.&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL.&#xD;
&#xD;
               -  AST or ALT ≤ 2.5 × upper limit of normal (ULN) (or ≤ 5 × ULN in the context of&#xD;
                  liver metastasis).&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 × ULN.&#xD;
&#xD;
               -  Creatinine clearance ≥ 45 mL/min/1.73 m2 (measured or estimated).&#xD;
&#xD;
               -  Albumin ≥ 3 g/dL (≥ 30 g/L) .&#xD;
&#xD;
          -  If patient has undergone surgery of the gastrointestinal or hepatobiliary tract,&#xD;
             adequate absorption as evidenced by: albumin ≥ 3.0 g/dL, controlled pancreatic&#xD;
             insufficiency (if present), and lack of malabsorption.&#xD;
&#xD;
          -  Able to swallow and retain oral medication and does not have uncontrolled emesis.&#xD;
&#xD;
          -  Able to comply with protocol requirements.&#xD;
&#xD;
          -  Negative pregnancy test for patients of childbearing potential. Patients of&#xD;
             childbearing potential must use appropriate precautions to avoid pregnancy, defined as&#xD;
             of non-childbearing potential (ie, postmenopausal or permanently sterilized) or using&#xD;
             highly effective contraception with low user-dependency, for at least 3 months after&#xD;
             the last dose of relacorilant, or per the duration indicated in the product label for&#xD;
             nab-paclitaxel, whichever is latest. A woman is postmenopausal if it is more than 12&#xD;
             months since her last menstruation, without an alternative medical cause. Accepted&#xD;
             methods of permanent sterilization methods are hysterectomy, bilateral salpingectomy&#xD;
             and/or bilateral oophorectomy. Accepted methods of highly effective contraception with&#xD;
             low user-dependency are:&#xD;
&#xD;
               -  An IUD, provided that the subject has tolerated its use for at least 3 months&#xD;
                  before the first dose of study medication and undertakes not to have it removed&#xD;
                  for 1 month after the last dose.&#xD;
&#xD;
               -  Abstinence from heterosexual intercourse, when it is in line with the subject's&#xD;
                  preferred and usual lifestyle. Periodic abstinence and withdrawal are NOT&#xD;
                  acceptable.&#xD;
&#xD;
               -  Vasectomized partner provided that the partner is the sole sexual partner of the&#xD;
                  trial participant and that the vasectomized partner has received medical&#xD;
                  assessment of the surgical success.&#xD;
&#xD;
               -  Oral hormonal contraceptives are NOT permitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy&#xD;
             that in the opinion of the Investigator has not resolved to Grade 1 or less prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Any major surgery within 4 weeks prior to randomization. If subject received major&#xD;
             surgery including (curative or palliative surgery), they must have recovered&#xD;
             adequately from the toxicity and/or complications from the intervention prior to&#xD;
             starting therapy.&#xD;
&#xD;
          -  Treatment with the following prior to randomization:&#xD;
&#xD;
               -  Concurrent treatment with other anticancer therapy including other chemotherapy,&#xD;
                  immunotherapy, radiotherapy, chemoembolization, targeted therapy, an&#xD;
                  investigational agent or the non-approved use of a drug or device within 28 days&#xD;
                  before the first dose of study drug.&#xD;
&#xD;
               -  Hormonal anticancer therapies within 7 days of the first dose of study drug.&#xD;
&#xD;
               -  Systemic, inhaled, or prescription strength topical corticosteroids within 21&#xD;
                  days of the first dose of study drug. Short courses (≤ 5 days) for&#xD;
                  non-cancer-related reasons are allowed if clinically required (such as&#xD;
                  prophylaxis for CT).&#xD;
&#xD;
          -  Received radiation to more than 25% of marrow-bearing areas.&#xD;
&#xD;
          -  Toxicities of prior therapies (except alopecia) that have not resolved to National&#xD;
             Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 ≤&#xD;
             Grade 1.&#xD;
&#xD;
          -  Requirement for treatment with chronic or frequently used oral corticosteroids for&#xD;
             medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after&#xD;
             organ transplantation).&#xD;
&#xD;
          -  History of severe hypersensitivity or severe reaction to either study drug.&#xD;
&#xD;
          -  Peripheral neuropathy from any cause &gt; Grade 1.&#xD;
&#xD;
          -  Pregnant or lactating patients or patients expecting to conceive children within the&#xD;
             projected duration of the trial, starting with the screening visit through at least 3&#xD;
             months after the last dose of relacorilant, or per the duration indicated in the&#xD;
             product label for nab-paclitaxel, whichever is latest.&#xD;
&#xD;
          -  Human immunodeficiency virus or current chronic/active infection with hepatitis C&#xD;
             virus or hepatitis B virus, including:&#xD;
&#xD;
               -  Patients with chronic or active hepatitis B as diagnosed by serologic tests are&#xD;
                  excluded from the study. In equivocal cases, hepatitis B or C polymerase chain&#xD;
                  reaction may be performed and must be negative for enrollment.&#xD;
&#xD;
          -  Patient has a clinically significant uncontrolled condition(s) or which in the opinion&#xD;
             of the Investigator may confound the results of the trial or interfere with the&#xD;
             patient's participation, including but not limited to:&#xD;
&#xD;
               -  Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction&#xD;
                  6 months before study entry.&#xD;
&#xD;
               -  Uncontrolled hypertension (sustained systolic blood pressure &gt; 150 mmHg or&#xD;
                  diastolic pressure &gt; 100 mmHg despite optimal management). Patients will be&#xD;
                  considered eligible if hypertension is treated and controlled during Screening.&#xD;
&#xD;
               -  Active infection that requires parenteral antibiotics.&#xD;
&#xD;
               -  Bowel obstruction or gastric outlet obstruction.&#xD;
&#xD;
               -  Has known psychiatric or substance abuse disorders that would interfere with&#xD;
                  cooperation with the requirements of the trial.&#xD;
&#xD;
          -  Untreated parenchymal central nervous system metastases.&#xD;
&#xD;
          -  Any other concurrent cancer or a history of another invasive malignancy within the&#xD;
             last 3 years that has a likelihood of recurrence of &gt; 30% within the next 5 years.&#xD;
             Adequately treated non-melanoma skin cancers or non-muscle invasive urothelial cancer&#xD;
             or other tumors curatively treated with no evidence of disease are permissible.&#xD;
&#xD;
          -  Are taking a concomitant medication that is a strong CYP3A inhibitor or inducer, or&#xD;
             that is a substrate of CYP3A with a narrow therapeutic window.&#xD;
&#xD;
          -  Concurrent treatment with mifepristone or other glucocorticoid receptor (GR)&#xD;
             antagonists.&#xD;
&#xD;
          -  Drugs with a narrow therapeutic ratio that are highly dependent on CYP3A for clearance&#xD;
             should be avoided. Caution should be exercised when co-administering known inhibitors&#xD;
             of CYP3A with relacorilant. Medicines/food known to strongly inhibit CYP3A should be&#xD;
             avoided.&#xD;
&#xD;
          -  Concurrent treatment on other investigational treatment studies for the treatment of&#xD;
             ovarian, fallopian tube, or primary peritoneal cancer.&#xD;
&#xD;
          -  Has received a live vaccine within 30 days of planned start of study therapy. Note:&#xD;
             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and&#xD;
             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live&#xD;
             attenuated vaccines, and are not allowed.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer will be considered for this study</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndah Dreiling, MD</last_name>
    <role>Study Director</role>
    <affiliation>Corcept Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #004</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #038</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #032</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #001</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #106</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #051</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #127</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #135</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #121</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #109</name>
      <address>
        <city>Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #119</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #108</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #117</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #096</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #122</name>
      <address>
        <city>Milan</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #112</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #124</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #115</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #114</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #116</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #113</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>June 27, 2022</last_update_submitted>
  <last_update_submitted_qc>June 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glucocorticoid Receptor</keyword>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Fallopian Tube Cancer</keyword>
  <keyword>Primary Peritoneal Cancer</keyword>
  <keyword>Nab-paclitaxel</keyword>
  <keyword>GR Antagonist</keyword>
  <keyword>Relacorilant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03776812
org study id: CORT125134-552
nct id: NCT03776812
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 2, open-label, randomized, 3-arm study to evaluate progression-free survival
      (PFS) in patients with recurrent platinum-resistant ovarian, fallopian tube, or primary
      peritoneal cancer treated with intermittent or continuous regimens of relacorilant in
      combination with nab-paclitaxel compared with patients treated with nab-paclitaxel alone.
Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR). The goals of
      this study are to evaluate the efficacy of relacorilant either administered daily
      (continuous) or on the day prior, the day of, and the day after chemotherapy (intermittent)
      in combination with nab-paclitaxel in the treatment of platinum-resistant ovarian, fallopian
      tube, or primary peritoneal cancers compared with nab-paclitaxel alone. The safety,
      pharmacokinetics (PK), and pharmacodynamic profile of relacorilant in combination with
      nab-paclitaxel will also be assessed.

      Eligible patients will be randomized 1:1:1 to one of the following three treatment arms.
      Patient randomization will be stratified by treatment-free interval from most recent taxane
      (relapsed within 6 months vs >6 months) and presence of ascites (yes vs no).

        -  Arm A (Continuous relacorilant): Relacorilant starting at 100mg, administered orally,
           once daily every day in combination with nab-paclitaxel on Days 1, 8, and 15 of each
           28-day cycle.

        -  Arm B (Intermittent relacorilant): Relacorilant 150mg, administered orally, on the day
           before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in
           combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

        -  Arm C (Comparator): Nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

      Patients will remain on study treatment until reaching a protocol-defined event of disease
      progression (PD), experiencing unmanageable toxicity, or until other treatment
      discontinuation criteria are met. All patients will be followed for progression, subsequent
      therapies and survival. Patients in Arm C who experience unequivocal PD per RECIST v1.1 will
      be given the opportunity to receive relacorilant in combination with nab-paclitaxel after
      discussion with the Medical Monitor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS)
time frame: 12 months from enrollment of last subject
description: Time from randomization until the date first documented of progressive disease (PD) by RECIST v1.1 (as determined by the Investigator at the local site), or death due to any cause, whichever occurs first
measure: Objective Response Rate (ORR)
time frame: 12 months from enrollment of last subject
description: Proportion of patients with measurable disease at baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1 (confirmation not required).
measure: Duration of Response (DoR)
time frame: 12 months from enrollment of last subject
description: Time from when response (CR or PR) was first documented to first objectively documented PD or death (whichever occurs first)
measure: Response according to Gynecological Cancer Intergroup criteria (GCIG)
time frame: 12 months from enrollment of last subject
description: Overall response per Gynecological Cancer Intergroup criteria (GCIG)
measure: Best Overall Response (BoR)
time frame: 12 months from enrollment of last subject
description: Best response recorded from the date of randomization until PD/recurrence (or death)
measure: Progression Free Survival (PFS) Rate
time frame: 12 months from enrollment of last subject
description: Proportion of patients who have not progressed at 6 and 12 months
measure: PFS in patients who crossover to continuous treatment at time of PD
time frame: 12 months from enrollment of last subject
description: Time from randomization until the earliest date of progressive disease (PD) by RECIST v1.1, as determined by the Investigator at the local site, or death from any cause, whichever occurs first
measure: Overall Response Rate in patients who crossover to continuous treatment at time of PD
time frame: 12 months from enrollment of last subject
description: Proportion of patients with measurable disease at baseline who attain confirmed complete response (CR) or partial response (PR) by RECIST v1.1
measure: Duration of Response in patients who crossover to continuous treatment at time of PD
time frame: 12 months from enrollment of last subject
description: Time from when response (CR or PR) was first documented to first objectively documented PD or death (whichever occurs first)
measure: Best Overall Response in patients who crossover to continuous treatment at time of PD
time frame: 12 months from enrollment of last subject
description: Proportion of patients with measurable disease at baseline who attain CR or PR by RECIST v1.1
measure: Cancer Antigen (CA)-125 Response
time frame: 12 months from enrollment of last subject
description: CA-125 response will be assessed per GCIG criteria defined as >/=50% reduction in CA-125 from a pre-treatment sample and maintained for >/- 28 days in patients with a pre-treatment sample that is at least twice the upper limit of the reference range and within 2 weeks before starting the treatment. In addition, patients who have a CA-125 response and whose CA-125 level falls to within the reference range will be classified as CA-125 complete responders.
measure: Overall survival
time frame: 12 months from enrollment of last subject
description: Time from randomization to death by any cause
measure: Combined Response according to RECIST v1.1 + GCIG criteria
time frame: 12 months from enrollment of last subject
description: To assess combined response by RECIST 1.1 with GCIG criteria
arm group label: Continuous Relacorilant Dosing
arm group type: Experimental
description: Patients will be treated with relacorilant, administered orally, once daily every day in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
arm group label: Intermittent Relacorilant Dosing
arm group type: Experimental
description: Patients will be treated with relacorilant, administered orally, on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
arm group label: Nab-paclitaxel Comparator
arm group type: Active Comparator
description: Patients will receive nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
intervention type: Drug
intervention name: Relacorilant, 100mg QD
description: Relacorilant is supplied as capsules for oral dosing
arm group label: Continuous Relacorilant Dosing
other name: CORT125134
intervention type: Drug
intervention name: Nab-paclitaxel, 80mg/m^2
description: Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle
arm group label: Continuous Relacorilant Dosing
arm group label: Intermittent Relacorilant Dosing
other name: Abraxane
intervention type: Drug
intervention name: Nab-paclitaxel, 100mg/m^2
description: Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle
arm group label: Nab-paclitaxel Comparator
other name: Abraxane
intervention type: Drug
intervention name: Relacorilant, 150mg QD
description: Relacorilant is supplied as capsules for oral dosing
arm group label: Intermittent Relacorilant Dosing
other name: CORT125134
criteria: 
gender: Female
gender based: Yes
gender description: Only patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer will be considered for this study
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lyndah Dreiling, MD
role: Study Director
affiliation: Corcept Therapeutics
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country: Belgium
country: Canada
country: Italy
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Ovarian Neoplasms
mesh term: Recurrence
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
sharing ipd: No