<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/NCT04502602</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-18-14152</org_study_id>
    <secondary_id>NCI-2020-05315</secondary_id>
    <nct_id>NCT04502602</nct_id>
  </id_info>
  <brief_title>Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer</brief_title>
  <acronym>iNNOVATE</acronym>
  <official_title>A Phase 1/1b Clinical Trial of Niraparib and Neratinib in Advanced Solid Tumors With an Expansion Cohort in Platinum-resistant Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Puma Biotechnology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in&#xD;
      patients with advanced solid tumors during Phase 1. To evaluate clinical benefit (≥4-month&#xD;
      progression-free survival [PFS]) of niraparib and neratinib in patients with&#xD;
      platinum-resistant ovarian cancer in Phase 1b.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a single-arm, open-label, phase 1/1b trial to determine the RP2D of neratinib&#xD;
      and niraparib when given in combination to patients with advanced solid tumors. The RP2D will&#xD;
      be identified during the phase 1 dose escalation portion of the study using a modified 3+3&#xD;
      design and evaluated in a phase 1b dose expansion cohort of up to 12 patients with&#xD;
      platinum-resistant ovarian cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2029</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Dose escalation will proceed within each cohort. Phase 1b is the expansion cohort at the recommended phase 2 dose found in phase 1.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: To determine the Recommended phase 2 dose (RP2D) of niraparib and neratinib in patients with advanced solid tumors</measure>
    <time_frame>4 Months</time_frame>
    <description>The RP2D will be identified during the phase 1 dose escalation portion of the study using a modified 3+3 design and evaluated in a phase 1b dose expansion cohort of up to 12 patients with platinum-resistant ovarian cancer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1b: To evaluate clinical benefit (≥4-month progression-free survival [PFS]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer.</measure>
    <time_frame>4 months</time_frame>
    <description>Phase 1b: To evaluate clinical benefit (≥4-month progression-free survival [PFS]) of niraparib and neratinib given at the RP2D to in patients with platinum-resistant ovarian cancer. To evaluate the clinical benefit, (defined as ≥4-month progression free survival (PFS), using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria in patients with platinum-resistant ovarian cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the frequency of adverse events (AEs)</measure>
    <time_frame>5 months</time_frame>
    <description>To assess adverse events (AEs) characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V 5.0) to determine safety and toxicity of the combination of neratinib and niraparib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary efficacy (objective response rate [ORR]) of niraparib and neratinib in patients with advanced solid tumors.</measure>
    <time_frame>5 years</time_frame>
    <description>To evaluate the objective response rate (ORR): The percentage of patients with objective response either partial response (PR) or complete response(CR), by analysis using RECIST 1.1 criteria</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Level -1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neratinib 160 mg and Niraparib 100 mg by mouth once daily for 28 day cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neratinib 160 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neratinib 200 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Level 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neratinib 240 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Level 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neratinib 240 mg and Niraparib 300 mg by mouth once daily for 28 day cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1b: Platinum Resistant Expansion Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This portion of the study provides for cohort expansion to observe for 4 month or greater progression-free survival in patients with platinum resistant ovarian cancer treated at the recommended phase 2 dose (RP2D) determined in Phase I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neratinib 160 mg</intervention_name>
    <description>Escalating doses to determine recommended phase 2 dose (RP2D)</description>
    <arm_group_label>Dose Level -1</arm_group_label>
    <arm_group_label>Dose Level 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neratinib 200 mg</intervention_name>
    <description>Determined RP2D dose</description>
    <arm_group_label>Dose Level 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neratinib 240 mg</intervention_name>
    <description>Escalating doses to determine recommended phase 2 dose (RP2D)</description>
    <arm_group_label>Dose Level 3</arm_group_label>
    <arm_group_label>Dose Level 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib 100 mg</intervention_name>
    <description>Escalating doses to determine recommended phase 2 dose (RP2D)</description>
    <arm_group_label>Dose Level -1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib 200 mg</intervention_name>
    <description>Escalating doses to determine recommended phase 2 dose (RP2D)</description>
    <arm_group_label>Dose Level 1</arm_group_label>
    <arm_group_label>Dose Level 2</arm_group_label>
    <arm_group_label>Dose Level 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib 300 mg</intervention_name>
    <description>Phase 1: Escalating doses to determine recommended phase 2 dose (RP2D)</description>
    <arm_group_label>Dose Level 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib at RP2D</intervention_name>
    <description>Phase 1b: Determined dose</description>
    <arm_group_label>Phase 1b: Platinum Resistant Expansion Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neratinib at RP2D</intervention_name>
    <description>Phase 1b: Determined dose</description>
    <arm_group_label>Phase 1b: Platinum Resistant Expansion Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Disease Characteristics&#xD;
&#xD;
          -  Phase 1: Patients with advanced solid tumors, excluding primary CNS and prostate&#xD;
             tumors, that have progressed during or after treatment with approved therapies or for&#xD;
             which there is no standard effective therapy available or&#xD;
&#xD;
          -  Phase 1b: Female patients with ovarian cancer who:&#xD;
&#xD;
          -  Are platinum resistant (progressed within 6 months of finishing platinum therapy) and&#xD;
&#xD;
          -  Have received at least 2 prior lines of therapy and&#xD;
&#xD;
          -  Do not have a BRCA germline mutation&#xD;
&#xD;
          -  Measurable or evaluable disease by RECIST 1.1&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  Adequate bone marrow function as defined below:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,500/mm3&#xD;
&#xD;
               -  Platelets ≥ 100,000/mm3 (untransfused)&#xD;
&#xD;
               -  Hemoglobin ≥9 g/dL (untransfused)&#xD;
&#xD;
          -  Adequate renal function as defined below:&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x upper limit of normal (ULN) for the laboratory OR&#xD;
                  calculated&#xD;
&#xD;
               -  Or actual creatinine clearance ≥ 30 mL/min (see Appendix 2 for the&#xD;
                  Cockcroft-Gault formula for calculating creatinine clearance)&#xD;
&#xD;
          -  Adequate hepatic function as defined below:&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x ULN for the laboratory OR direct bilirubin ≤ 1.0 x ULN&#xD;
&#xD;
               -  Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 3x ULN&#xD;
                  when liver metastases are present)&#xD;
&#xD;
          -  Patients receiving corticosteroids may continue as long as their dose is stable for&#xD;
             least 4 weeks prior to initiating protocol therapy&#xD;
&#xD;
          -  Patients must agree not to donate blood during the study or for 90 days after the last&#xD;
             dose of study treatment&#xD;
&#xD;
          -  A woman of childbearing potential (WCBP) must have a documented negative serum&#xD;
             pregnancy test within 7 days prior to initiating study treatment and agree to abstain&#xD;
             from activities that could result in pregnancy from screening through 90 days after&#xD;
             the last dose of study treatment. Non Childbearing potential is defined as follows (by&#xD;
             other than medical reasons):&#xD;
&#xD;
               -  ≥45 years of age and has not had menses for &gt;1 year&#xD;
&#xD;
               -  Patients who have been amenorrhoeic for &lt;2 years without history of a&#xD;
                  hysterectomy and oophorectomy must have a follicle stimulating hormone (FSH)&#xD;
                  value in the postmenopausal range upon screening evaluation&#xD;
&#xD;
               -  Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.&#xD;
                  Documented hysterectomy or oophorectomy must be confirmed with medical records of&#xD;
                  the actual procedure or confirmed by an ultrasound. Tubal ligation must be&#xD;
                  confirmed with medical records of the actual procedure, otherwise the patient&#xD;
                  must be willing to use 2 adequate barrier methods throughout the study, starting&#xD;
                  with the screening visit through 180 days after the last dose of study treatment.&#xD;
                  Information must be captured appropriately within the site's source documents.&#xD;
                  Note: Abstinence is acceptable if this is the established and preferred&#xD;
                  contraception for the patient.&#xD;
&#xD;
          -  Participant must agree to not breastfeed during the study or for 30 days after the&#xD;
             last dose of study treatment.&#xD;
&#xD;
          -  Male participant agrees to use an adequate method of contraception starting with the&#xD;
             first dose of study treatment through 90 days after the last dose of study treatment.&#xD;
             Note: Abstinence is acceptable if this is the established and preferred contraception&#xD;
             for the patient.&#xD;
&#xD;
          -  Participant must agree to not donate sperm during the study or for 90 days after the&#xD;
             last dose of study treatment&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any investigational agent within 4 weeks, or within a time interval less than at least&#xD;
             5 half-lives of the investigational agent, whichever is shorter, prior to initiating&#xD;
             study treatment&#xD;
&#xD;
          -  Simultaneous enrollment in any other interventional clinical trial&#xD;
&#xD;
          -  Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not&#xD;
             controlled with oral repletion&#xD;
&#xD;
          -  Serious (ie, grade ≥ 3) uncontrolled infection&#xD;
&#xD;
          -  Major surgery ≤ 3 weeks prior to initiating study treatment and patient must have&#xD;
             recovered from any surgical effects.&#xD;
&#xD;
          -  Radiation encompassing &gt;20% of the bone marrow within 2 weeks, or any radiation&#xD;
             therapy within 1 week, prior to initiating study treatment.&#xD;
&#xD;
          -  Transfusion of platelets or red blood cells ≤ 4 weeks prior to initiating study&#xD;
             treatment&#xD;
&#xD;
          -  Receipt of colony-stimulating factors (e.g., granulocyte colony-stimulating factor&#xD;
             [GCSF], granulocyte macrophage colony- stimulating factor [GM-CSF], or recombinant&#xD;
             erythropoietin) within 4 weeks prior to initiating study treatment&#xD;
&#xD;
          -  Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)&#xD;
&#xD;
          -  Known brain or leptomeningeal metastasis&#xD;
&#xD;
          -  Diagnosis, detection, or treatment of another type of invasive cancer ≤ 2 years prior&#xD;
             to initiating study treatment&#xD;
&#xD;
          -  Active or clinically significant cardiac disease including any of the following;&#xD;
&#xD;
               -  Unstable angina (eg, angina symptoms at rest) or onset of angina within 3 months&#xD;
                  prior to initiating study treatment&#xD;
&#xD;
               -  Myocardial infarction diagnoses within 6 months prior to initiating study&#xD;
                  treatment&#xD;
&#xD;
               -  New York Heart Association (NYHA) class III or IV congestive heart failure&#xD;
&#xD;
               -  Uncontrolled hypertension&#xD;
&#xD;
          -  Inability to swallow medication&#xD;
&#xD;
          -  Known hypersensitivity to niraparib or neratinib components or excipients&#xD;
&#xD;
          -  Known or suspected malabsorption condition or obstruction Note: Use of pancreatic&#xD;
             enzyme supplements is allowed to control malabsorption&#xD;
&#xD;
          -  Inability to shift medications as follows:&#xD;
&#xD;
               -  Antacids (eg, calcium carbonate): dose at least 3 hours after dosing with&#xD;
                  neratinib&#xD;
&#xD;
               -  H2 receptor antagonists: dose must be taken at least 2 hours after or 10 hours&#xD;
                  before dosing with neratinib&#xD;
&#xD;
          -  Planned ongoing treatment with other drugs thought to potentially have adverse&#xD;
             interactions with either of the medications included in the study treatment:&#xD;
&#xD;
               -  Proton pump inhibitors (PPIs). Must discontinue use 10 days prior to initiating&#xD;
                  study therapy.&#xD;
&#xD;
               -  High-risk P-glycoprotein (P-gp) substrates (eg, digoxin, dabigatran).&#xD;
&#xD;
               -  Strong or moderate CYP3A4 inhibitors and/or Strong or moderate CYP3A4 inducers.&#xD;
                  Examples of clinical inhibitors and clinical inducers for P450-mediated&#xD;
                  metabolism and classification of strong, moderate, and weak interactions are&#xD;
                  available through the FDA website:&#xD;
                  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInte&#xD;
                  ractionsLabeling/ucm093664.htm&#xD;
&#xD;
               -  If such medications have been used, patients must have discontinued these agents&#xD;
                  ≥ 2 weeks prior to initiating study treatment.&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Medical, psychological, or social condition that, in the opinion of the investigator,&#xD;
             may increase the patient's risk or limit the patient's adherence with study&#xD;
             requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Poklepovic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massey Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Massey SIIT Team</last_name>
    <phone>804-628-9238</phone>
    <email>masseysiit@vcu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Massey Team Echo</last_name>
    <email>ctoclinops@vcu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massey SIIT Team</last_name>
      <phone>804-628-9238</phone>
      <email>masseysiit@vcu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Massey Team Echo</last_name>
      <email>ctoclinops@vcu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niraparib</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/NCT04502602
org study id: MCC-18-14152
secondary id: NCI-2020-05315
nct id: NCT04502602
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in
      patients with advanced solid tumors during Phase 1. To evaluate clinical benefit (≥4-month
      progression-free survival [PFS]) of niraparib and neratinib in patients with
      platinum-resistant ovarian cancer in Phase 1b.
This study is a single-arm, open-label, phase 1/1b trial to determine the RP2D of neratinib
      and niraparib when given in combination to patients with advanced solid tumors. The RP2D will
      be identified during the phase 1 dose escalation portion of the study using a modified 3+3
      design and evaluated in a phase 1b dose expansion cohort of up to 12 patients with
      platinum-resistant ovarian cancer.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Dose escalation will proceed within each cohort. Phase 1b is the expansion cohort at the recommended phase 2 dose found in phase 1.
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1: To determine the Recommended phase 2 dose (RP2D) of niraparib and neratinib in patients with advanced solid tumors
time frame: 4 Months
description: The RP2D will be identified during the phase 1 dose escalation portion of the study using a modified 3+3 design and evaluated in a phase 1b dose expansion cohort of up to 12 patients with platinum-resistant ovarian cancer.
measure: Phase 1b: To evaluate clinical benefit (≥4-month progression-free survival [PFS]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer.
time frame: 4 months
description: Phase 1b: To evaluate clinical benefit (≥4-month progression-free survival [PFS]) of niraparib and neratinib given at the RP2D to in patients with platinum-resistant ovarian cancer. To evaluate the clinical benefit, (defined as ≥4-month progression free survival (PFS), using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria in patients with platinum-resistant ovarian cancer.
measure: To assess the frequency of adverse events (AEs)
time frame: 5 months
description: To assess adverse events (AEs) characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V 5.0) to determine safety and toxicity of the combination of neratinib and niraparib
measure: Preliminary efficacy (objective response rate [ORR]) of niraparib and neratinib in patients with advanced solid tumors.
time frame: 5 years
description: To evaluate the objective response rate (ORR): The percentage of patients with objective response either partial response (PR) or complete response(CR), by analysis using RECIST 1.1 criteria
arm group label: Dose Level -1
arm group type: Experimental
description: Neratinib 160 mg and Niraparib 100 mg by mouth once daily for 28 day cycles.
arm group label: Dose Level 1
arm group type: Experimental
description: Neratinib 160 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
arm group label: Dose Level 2
arm group type: Experimental
description: Neratinib 200 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
arm group label: Dose Level 3
arm group type: Experimental
description: Neratinib 240 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
arm group label: Dose Level 4
arm group type: Experimental
description: Neratinib 240 mg and Niraparib 300 mg by mouth once daily for 28 day cycles.
arm group label: Phase 1b: Platinum Resistant Expansion Cohort
arm group type: Experimental
description: This portion of the study provides for cohort expansion to observe for 4 month or greater progression-free survival in patients with platinum resistant ovarian cancer treated at the recommended phase 2 dose (RP2D) determined in Phase I.
intervention type: Drug
intervention name: Neratinib 160 mg
description: Escalating doses to determine recommended phase 2 dose (RP2D)
arm group label: Dose Level -1
arm group label: Dose Level 1
intervention type: Drug
intervention name: Neratinib 200 mg
description: Determined RP2D dose
arm group label: Dose Level 2
intervention type: Drug
intervention name: Neratinib 240 mg
description: Escalating doses to determine recommended phase 2 dose (RP2D)
arm group label: Dose Level 3
arm group label: Dose Level 4
intervention type: Drug
intervention name: Niraparib 100 mg
description: Escalating doses to determine recommended phase 2 dose (RP2D)
arm group label: Dose Level -1
intervention type: Drug
intervention name: Niraparib 200 mg
description: Escalating doses to determine recommended phase 2 dose (RP2D)
arm group label: Dose Level 1
arm group label: Dose Level 2
arm group label: Dose Level 3
intervention type: Drug
intervention name: Niraparib 300 mg
description: Phase 1: Escalating doses to determine recommended phase 2 dose (RP2D)
arm group label: Dose Level 4
intervention type: Drug
intervention name: Niraparib at RP2D
description: Phase 1b: Determined dose
arm group label: Phase 1b: Platinum Resistant Expansion Cohort
intervention type: Drug
intervention name: Neratinib at RP2D
description: Phase 1b: Determined dose
arm group label: Phase 1b: Platinum Resistant Expansion Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Poklepovic, MD
role: Principal Investigator
affiliation: Massey Cancer Center
last name: Massey SIIT Team
phone: 804-628-9238
email: masseysiit@vcu.edu
last name: Massey Team Echo
email: ctoclinops@vcu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Niraparib
sharing ipd: No