<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/NCT02985125</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0232</org_study_id>
    <nct_id>NCT02985125</nct_id>
  </id_info>
  <brief_title>LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy</brief_title>
  <official_title>A Phase I/II Study of LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Virginia Mason Hospital/Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single-arm, open-label, multi-institutional Phase I/II trial of the&#xD;
      combination of LEE011 and everolimus in refractory mPAC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm, open label Phase I/II study to evaluate the progression free survival&#xD;
      at 8 weeks (PFS8week) of the combination of LEE-011 plus everolimus, in patients with&#xD;
      metastatic pancreatic cancer refractory to 5-fluorouracil (5-FU) and gemcitabine-based&#xD;
      chemotherapy. Previous studies of third-line therapy in mPAC are limited but reveal stable&#xD;
      disease in 25-31% of patients with no partial or complete responses (31% of patients in the&#xD;
      GVAX/CRS-207 combination vaccine study had stable disease but only 52% of these patients were&#xD;
      treated in the third-line setting). It is hoped that the combination of LEE-011 plus&#xD;
      everolimus can increase the PFS8weeks to at least 50%, though early stopping rules are in&#xD;
      place for lack of efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (PFS) rate at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>PFS at 8 weeks in a patient with refractory mPAC treated with LEE011 and everolimus, defined as positive if a patient does not have evidence of progressive disease at 8 weeks as measured by expert radiologists using RECIST v1.1 criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>PFS in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to progressive disease (as measured by expert radiologists using RECIST v1.1 criteria), death from any cause, or last follow-up, as determined by the investigator of LEE011 and everolimus in patients with mPAC refractory to chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>2 years</time_frame>
    <description>Overall survival (OS) in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to death from any cause or last follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best response in a patient using RECIST v1.1 criteria</measure>
    <time_frame>2 years</time_frame>
    <description>Best response in a patient, defined as the largest percent decrease in tumor size from baseline and categorized as a complete response, partial response, or stable disease by imaging studies, measured by expert radiologists using RECIST v1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events as accessed by NCI CTCAE v4.03</measure>
    <time_frame>2 years</time_frame>
    <description>Adverse events in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the number of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.03) that occur after Cycle 1, Day 1</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Metastatic Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Phase I - Dose Level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment cycles are 28 days long.&#xD;
LEE011 (taken orally) - 250mg Once daily on days 1-21&#xD;
Everolimus (taken orally) - 2.5mg Once daily on days 1-28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I - Dose Level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment cycles are 28 days long.&#xD;
LEE011 (taken orally) - 300mg Once daily on days 1-21&#xD;
Everolimus (taken orally) - 2.5mg Once daily on days 1-28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I - Dose Level -1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment cycles are 28 days long.&#xD;
LEE011 (taken orally) - 200mg Once daily on days 1-21&#xD;
Everolimus (taken orally) - 2.5mg Once daily on days 1-28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I - Dose Level -2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment cycles are 28 days long.&#xD;
LEE011 (taken orally) - 150mg Once daily on days 1-21&#xD;
Everolimus (taken orally) - 2.5mg Once daily on days 1-28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II - Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment cycles are 28 days long.&#xD;
LEE011 (taken orally) - the recommended phase II dose Once daily on days 1-21&#xD;
Everolimus (taken orally) - 2.5mg Once daily on days 1-28</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEE011</intervention_name>
    <description>Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm.</description>
    <arm_group_label>Phase I - Dose Level -1</arm_group_label>
    <arm_group_label>Phase I - Dose Level -2</arm_group_label>
    <arm_group_label>Phase I - Dose Level 1</arm_group_label>
    <arm_group_label>Phase I - Dose Level 2</arm_group_label>
    <arm_group_label>Phase II - Dose</arm_group_label>
    <other_name>ribociclib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus</intervention_name>
    <description>Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.</description>
    <arm_group_label>Phase I - Dose Level -1</arm_group_label>
    <arm_group_label>Phase I - Dose Level -2</arm_group_label>
    <arm_group_label>Phase I - Dose Level 1</arm_group_label>
    <arm_group_label>Phase I - Dose Level 2</arm_group_label>
    <arm_group_label>Phase II - Dose</arm_group_label>
    <other_name>Afinitor®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed mPAC (mixed histology is acceptable as long as the&#xD;
             predominant histology is pancreatic adenocarcinoma)&#xD;
&#xD;
          2. Patient must consent to two mandatory biopsies and have tumor amenable to biopsy&#xD;
&#xD;
          3. Measurable disease by RECIST v1.1 criteria (tumor ≥ 1 cm in longest diameter on axial&#xD;
             image on CT or MRI and/or lymph node(s) ≥ 1.5 cm in short axis on CT or MRI) on&#xD;
             baseline imaging&#xD;
&#xD;
          4. Documented progression of disease on at least one 5-FU-based regimen and at least one&#xD;
             GEM-based regimen for metastatic disease (progression during or within 3 months of the&#xD;
             completion of adjuvant therapy is acceptable)&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (see Table 2)&#xD;
&#xD;
          6. Age ≥ 18 years&#xD;
&#xD;
          7. Subjects with no brain metastases or a history of previously treated brain metastases&#xD;
             who have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks&#xD;
             prior to enrollment and have a baseline MRI that shows no evidence of active&#xD;
             intracranial disease&#xD;
&#xD;
          8. Patients with available standard 12-lead ECG with the following parameters at&#xD;
             screening (defined as the mean of the triplicate ECGs):&#xD;
&#xD;
               -  QTcF interval at screening &lt;450msec&#xD;
&#xD;
               -  Resting heart rate 50-90bpm&#xD;
&#xD;
          9. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3; Platelets ≥100 ×&#xD;
             109/L; hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
             • Patients may have a transfusion of red blood cells to meet the hemoglobin&#xD;
             requirement&#xD;
&#xD;
         10. Renal function: serum creatinine ≤ 1.5 × upper normal limit of institution's normal&#xD;
             range or creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels&#xD;
             above institutional normal&#xD;
&#xD;
         11. Hepatic function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)&#xD;
             ≤ 3.0 × the upper normal limit of institution's normal range. Total bilirubin ≤ 1.5 ×&#xD;
             the upper normal limit of institution's normal range. For subjects with liver&#xD;
             metastases, AST and ALT &lt; 5 × the upper normal limit of institution's normal range,&#xD;
             and total bilirubin &gt;1.5 - 3.0 x the upper normal limit of institution's normal range&#xD;
             are acceptable as long as there is no persistent nausea, vomiting, right upper&#xD;
             quadrant pain or tenderness, fever, rash, or eosinophilia.&#xD;
&#xD;
         12. Partial Thromboplastin Time (PTT) must be ≤ 1.5 × upper normal limit of institution's&#xD;
             normal range and International Normalized Ratio (INR) &lt; 1.5. Subjects on anticoagulant&#xD;
             (such as warfarin) will be permitted to enroll as long s the INR is in the acceptable&#xD;
             therapeutic range as determined by the investigator.&#xD;
&#xD;
         13. Potassium, total calcium (corrected for serum albumin), magnesium, sodium and&#xD;
             phosphorus within normal limits for the institution or corrected to within normal&#xD;
             limits with supplements before first dose of study medication&#xD;
&#xD;
         14. Patients must have fully recovered from all effects of surgery. Patients must have had&#xD;
             at least two weeks after minor surgery and four weeks after major surgery before&#xD;
             starting therapy. Minor procedures requiring &quot;Twilight&quot; sedation such as endoscopies&#xD;
             or mediport placement may only require a 24-hour waiting period, but this must be&#xD;
             discussed with an investigator.&#xD;
&#xD;
         15. Women of childbearing potential must have a negative serum pregnancy test within 14&#xD;
             days prior to initiation of treatment and/or postmenopausal women must be amenorrheic&#xD;
             for at least 12 months to be considered of non-childbearing potential&#xD;
&#xD;
         16. Patient is capable of swallowing pills whole&#xD;
&#xD;
         17. Patient is capable of understanding and complying with parameters as outlined in the&#xD;
             protocol and able to sign and date the informed consent, approved by the Institutional&#xD;
             Review Board (IRB), prior to the initiation of any screening or study-specific&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients previously exposed to, intolerant of, or ineligible for Cyclin-dependent&#xD;
             kinase (CDK) inhibitors, Mammalian target of rapamycin (mTOR) inhibitors, and/or their&#xD;
             combination&#xD;
&#xD;
          2. Prior anti-tumor therapy within 3 weeks of Cycle 1 Day 1 (anti-tumor therapy defined&#xD;
             as, but is not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy,&#xD;
             and biologic therapy), radiotherapy, and investigational agents), the &quot;wash-out&#xD;
             period&quot;&#xD;
&#xD;
          3. Patient has any other concurrent severe and/or uncontrolled medical condition that&#xD;
             would, in the investigator's judgment, cause unacceptable safety risks, contraindicate&#xD;
             patient participation in the clinical study or compromise compliance with the protocol&#xD;
             (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled&#xD;
             fungal, bacterial or viral infections, etc.).&#xD;
&#xD;
          4. Women who are pregnant or breastfeeding&#xD;
&#xD;
          5. Concurrent use of CYP3A4 inhibiting or activating medications&#xD;
&#xD;
          6. Concurrent use of an Angiotensin-converting enzyme (ACE) inhibitor (increased risk of&#xD;
             angioedema with ACE inhibitors administered in combination with everolimus, seen in&#xD;
             approximately 6.8% of patients)&#xD;
&#xD;
          7. Psychiatric illness or social situation that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          8. Patient has a concurrent malignancy or malignancy within 3 years prior to starting&#xD;
             study drug, with the exception of adequately treated, basal or squamous cell&#xD;
             carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.&#xD;
&#xD;
          9. Patients with central nervous system (CNS) involvement unless they meet ALL of the&#xD;
             following criteria:&#xD;
&#xD;
               -  At least 4 weeks from prior therapy completion (including radiation and/or&#xD;
                  surgery) to starting the study treatment&#xD;
&#xD;
               -  Clinically stable CNS tumor at the time of screening and not receiving steroids&#xD;
                  and/or enzyme-inducing anti-epileptic medications for brain metastases.&#xD;
&#xD;
         10. Patient has impairment of gastrointestinal (GI) function or GI disease that may&#xD;
             significantly alter the absorption of the study drugs (e.g., ulcerative diseases,&#xD;
             uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel&#xD;
             resection).&#xD;
&#xD;
         11. Patient has a known history of HIV infection or chronic, active Hepatitis B (testing&#xD;
             not mandatory).&#xD;
&#xD;
         12. Patient has any other concurrent severe and/or uncontrolled medical condition that&#xD;
             would, in the investigator's judgment, cause unacceptable safety risks, contraindicate&#xD;
             patient participation in the clinical study or compromise compliance with the protocol&#xD;
             (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled&#xD;
             fungal, bacterial or viral infections, etc.).&#xD;
&#xD;
         13. Clinically significant, uncontrolled heart disease and/or cardiac repolarization&#xD;
             abnormalities, including any of the following:&#xD;
&#xD;
               -  History of acute coronary syndromes (including myocardial infarction, unstable&#xD;
                  angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or&#xD;
                  symptomatic pericarditis within 6 months prior to screening&#xD;
&#xD;
               -  History of documented congestive heart failure (New York Heart Association&#xD;
                  functional classification III-IV)&#xD;
&#xD;
               -  Documented cardiomyopathy&#xD;
&#xD;
               -  Left Ventricular Ejection Fraction (LVEF) &lt;50% as determined by Multiple Gated&#xD;
                  acquisition (MUGA) scan or echocardiogram (ECHO) at screening&#xD;
&#xD;
               -  Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia),&#xD;
                  complete left bundle branch block, high-grade Atrioventricular block (AV) block&#xD;
                  (e.g. bifascicular block, Mobitz type II and third-degree AV block)&#xD;
&#xD;
               -  Long QT syndrome or family history of idiopathic sudden death or congenital long&#xD;
                  QT syndrome, or any of the following:&#xD;
&#xD;
               -  Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or&#xD;
                  hypomagnesemia, history of cardiac failure, or history of clinically&#xD;
                  significant/symptomatic bradycardia.&#xD;
&#xD;
               -  Concomitant use of medication(s) with a known risk to prolong the QT interval&#xD;
                  and/or known to cause Torsades de Pointe that cannot be discontinued (within 5&#xD;
                  half-lives or 7 days prior to starting study drug) or replaced by safe&#xD;
                  alternative medication&#xD;
&#xD;
               -  Inability to determine the QT interval on screening (QTcF, using Fridericia's&#xD;
                  correction)&#xD;
&#xD;
               -  Systolic blood pressure (SBP) &gt;160 mmHg or &lt;90 mmHg at screening&#xD;
&#xD;
         14. Patient is currently receiving any of the following medications and cannot be&#xD;
             discontinued 7 days prior to starting study drug (see Table 4 for details):&#xD;
&#xD;
               -  Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit&#xD;
                  hybrids, pummelos, star-fruit, and Seville oranges&#xD;
&#xD;
               -  That have a narrow therapeutic window and are predominantly metabolized through&#xD;
                  CYP3A4/5&#xD;
&#xD;
               -  Herbal preparations/medications, dietary supplements.&#xD;
&#xD;
         15. Patient is currently receiving or has received systemic corticosteroids ≤2 weeks prior&#xD;
             to starting study drug, or who have not fully recovered from side effects of such&#xD;
             treatment.&#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>Benjamin Weinberg, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Lombardi Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lombardi Comprehensive Cancer Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreas</keyword>
  <keyword>5-FU</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>LEE011</keyword>
  <keyword>Everolimus</keyword>
  <keyword>Refractory</keyword>
  <keyword>Chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</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/NCT02985125
org study id: 2016-0232
nct id: NCT02985125
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a single-arm, open-label, multi-institutional Phase I/II trial of the
      combination of LEE011 and everolimus in refractory mPAC.
This is a single arm, open label Phase I/II study to evaluate the progression free survival
      at 8 weeks (PFS8week) of the combination of LEE-011 plus everolimus, in patients with
      metastatic pancreatic cancer refractory to 5-fluorouracil (5-FU) and gemcitabine-based
      chemotherapy. Previous studies of third-line therapy in mPAC are limited but reveal stable
      disease in 25-31% of patients with no partial or complete responses (31% of patients in the
      GVAX/CRS-207 combination vaccine study had stable disease but only 52% of these patients were
      treated in the third-line setting). It is hoped that the combination of LEE-011 plus
      everolimus can increase the PFS8weeks to at least 50%, though early stopping rules are in
      place for lack of efficacy.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS) rate at 8 weeks
time frame: 8 weeks
description: PFS at 8 weeks in a patient with refractory mPAC treated with LEE011 and everolimus, defined as positive if a patient does not have evidence of progressive disease at 8 weeks as measured by expert radiologists using RECIST v1.1 criteria
measure: Progression-free survival
time frame: 2 years
description: PFS in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to progressive disease (as measured by expert radiologists using RECIST v1.1 criteria), death from any cause, or last follow-up, as determined by the investigator of LEE011 and everolimus in patients with mPAC refractory to chemotherapy
measure: Overall survival (OS)
time frame: 2 years
description: Overall survival (OS) in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to death from any cause or last follow-up
measure: Best response in a patient using RECIST v1.1 criteria
time frame: 2 years
description: Best response in a patient, defined as the largest percent decrease in tumor size from baseline and categorized as a complete response, partial response, or stable disease by imaging studies, measured by expert radiologists using RECIST v1.1 criteria
measure: Number of adverse events as accessed by NCI CTCAE v4.03
time frame: 2 years
description: Adverse events in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the number of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.03) that occur after Cycle 1, Day 1
arm group label: Phase I - Dose Level 1
arm group type: Experimental
description: Treatment cycles are 28 days long.
LEE011 (taken orally) - 250mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28
arm group label: Phase I - Dose Level 2
arm group type: Experimental
description: Treatment cycles are 28 days long.
LEE011 (taken orally) - 300mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28
arm group label: Phase I - Dose Level -1
arm group type: Experimental
description: Treatment cycles are 28 days long.
LEE011 (taken orally) - 200mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28
arm group label: Phase I - Dose Level -2
arm group type: Experimental
description: Treatment cycles are 28 days long.
LEE011 (taken orally) - 150mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28
arm group label: Phase II - Dose
arm group type: Experimental
description: Treatment cycles are 28 days long.
LEE011 (taken orally) - the recommended phase II dose Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28
intervention type: Drug
intervention name: LEE011
description: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm.
arm group label: Phase I - Dose Level -1
arm group label: Phase I - Dose Level -2
arm group label: Phase I - Dose Level 1
arm group label: Phase I - Dose Level 2
arm group label: Phase II - Dose
other name: ribociclib
intervention type: Drug
intervention name: Everolimus
description: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.
arm group label: Phase I - Dose Level -1
arm group label: Phase I - Dose Level -2
arm group label: Phase I - Dose Level 1
arm group label: Phase I - Dose Level 2
arm group label: Phase II - Dose
other name: Afinitor®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Weinberg, MD
role: Study Chair
affiliation: Lombardi Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Everolimus
sharing ipd: No