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Exemestane in Post-Menopausal Women With NSCLC

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ClinicalTrials.gov Identifier: NCT02666105
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE January 22, 2016
First Posted Date  ICMJE January 28, 2016
Last Update Posted Date October 3, 2018
Actual Study Start Date  ICMJE September 27, 2018
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
  • Disease Response [ Time Frame: Day 42 ]
    Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Disease Response [ Time Frame: Day 84 ]
    Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Disease Response [ Time Frame: Day 126 ]
    Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02666105 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 30 days after the last dose of exemestane ]
    Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.
  • Response Duration [ Time Frame: Day 42 ]
    Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Response Duration [ Time Frame: Day 84 ]
    Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Response Duration [ Time Frame: Day 126 ]
    Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Progression-free survival [ Time Frame: 1 year after enrollment ]
    Progression-free survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Overall survival [ Time Frame: Day 42 ]
    Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Overall survival [ Time Frame: Day 84 ]
    Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Overall survival [ Time Frame: Day 126 ]
    Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Quality of Life [ Time Frame: Within 14 days of enrollment ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 21 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 42 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 63 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 84 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 105 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 126 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: 1 month post discontinuation of study treatment ]
    Quality of life will be assessed by use of PROMIS -29.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
  • Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 30 days after the last dose of exemestane ]
    Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.
  • Response Duration [ Time Frame: Day 42 ]
    Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Response Duration [ Time Frame: Day 84 ]
    Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Response Duration [ Time Frame: Day 126 ]
    Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Progression-free survival [ Time Frame: 1 year after enrollment ]
    Progression-free survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Overall survival [ Time Frame: Day 42 ]
    Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Overall survival [ Time Frame: Day 84 ]
    Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Overall survival [ Time Frame: Day 126 ]
    Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
  • Quality of Life [ Time Frame: Within 14 days of enrollment ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 21 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 42 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 63 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 84 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 105 ]
    Quality of life will be assessed by use of PROMIS -29.
  • Quality of Life [ Time Frame: Day 126 ]
    Quality of life will be assessed by use of PROMIS -29.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Exemestane in Post-Menopausal Women With NSCLC
Official Title  ICMJE Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer
Brief Summary This is a phase II single institution therapeutic study of adding exemestane therapy in post-menopausal women with advanced non-small cell lung cancer (NSCLC) who are progressing while on treatment with an immune checkpoint antibody (pembrolizumab, atezolizumab, or nivolumab).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Exemestane
One 25 mg tablet once daily for a minimum of 6 weeks
Other Name: Aromasin
Study Arms Experimental: Exemestane Therapy
Intervention: Drug: Exemestane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
29
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2016)
56
Estimated Study Completion Date February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab) NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis
  • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase - tumor block or a minimum of 5 unstained slides
  • Failed at least 1 prior FDA approved treatment for advanced NSCLC.
  • Measureable disease by RECIST version 1.1 (Appendix III)
  • Post-menopausal defined as

    • Age ≥ 55 years and 1 year or more of amenorrhea
    • Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL
    • Surgical menopause with bilateral oophorectomy
  • ECOG performance status 0, 1 or 2

    * Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record

  • Adequate organ function within 14 days of study enrollment defined as:

    • Hematology:

      • Absolute neutrophil count (ANC) ≥ 1500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 8 g/dL
      • International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution
    • Biochemistry:

      • Total Bilirubin within normal institutional limits
      • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
      • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min
  • Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e. peripheral neuropathy) is permitted.
  • A minimum time period must elapse between the end of a previous treatment and start of study therapy:

    • 1 week from the completion of radiation therapy for brain metastases
    • 4 weeks from the completion of chemotherapy or any experimental therapy
    • 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury)
  • Voluntary written consent before any research related procedures or therapy

Exclusion Criteria

  • Known active CNS disease - If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery - patients should be neurologically stable and requiring ≤10mg oral prednisone equivalence of steroids per day
  • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2
  • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity
  • Inability or unwilling to swallow study drug
  • Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
  • Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e. black cohosh)
  • Known hypersensitivity to exemestane or its excipients
  • Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment
  • Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Manish Patel, DO 612-624-6940 patel069@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02666105
Other Study ID Numbers  ICMJE 2015LS095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manish Patel, DO University of Minnesota Masonic Cancer Center
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP