Exemestane in Post-Menopausal Women With NSCLC
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ClinicalTrials.gov Identifier: NCT02666105 |
Recruitment Status :
Completed
First Posted : January 28, 2016
Last Update Posted : April 12, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Exemestane | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer |
Actual Study Start Date : | September 27, 2018 |
Actual Primary Completion Date : | February 28, 2022 |
Actual Study Completion Date : | February 28, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Exemestane Therapy |
Drug: Exemestane
One 25 mg tablet once daily for a minimum of 6 weeks
Other Name: Aromasin |
- 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).
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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. Patients with EGFR/ALK/ROS1 rearrangements should have received an FDA-approved TKI prior to enrollment on this trial.
- Measureable disease by RECIST version 1.1
-
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
-
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666105

Principal Investigator: | Manish Patel, DO | University of Minnesota Masonic Cancer Center |
Responsible Party: | Masonic Cancer Center, University of Minnesota |
ClinicalTrials.gov Identifier: | NCT02666105 |
Other Study ID Numbers: |
2015LS095 |
First Posted: | January 28, 2016 Key Record Dates |
Last Update Posted: | April 12, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NSCLC |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Exemestane Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |