Exemestane in Post-Menopausal Women With NSCLC

NCT ID: NCT02666105

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2022-02-28

Brief Summary

This is a phase II 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).

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exemestane Therapy

Group Type: EXPERIMENTAL

Exemestane

Intervention Type: DRUG

One 25 mg tablet once daily for a minimum of 6 weeks

Interventions

Exemestane

One 25 mg tablet once daily for a minimum of 6 weeks

Intervention Type: DRUG

Other Intervention Names

Aromasin

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manish Patel, DO

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Masonic Cancer Center

Locations

Mayo Clinic Health System

Albert Lea, Minnesota, United States

Essentia Health St. Joseph's Medical Center

Brainerd, Minnesota, United States

Essentia Health Deer River

Deer River, Minnesota, United States

Essentia Health St. Mary's Detroit Lakes

Detroit Lakes, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Essentia Health Fosston

Fosston, Minnesota, United States

Fairview Grand Itasca Clinic & Hospital

Grand Rapids, Minnesota, United States

Essentia Health Hibbing

Hibbing, Minnesota, United States

Fairview Range Medical Center

Hibbing, Minnesota, United States

Mayo Clinic Health System

Mankato, Minnesota, United States

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Monticello Cancer Center (MMCORC)

Monticello, Minnesota, United States

Essentia Health Park Rapids

Park Rapids, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, United States

Essentia Health Virginia

Virginia, Minnesota, United States

Sanford Worthington Medical Center

Worthington, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2015LS095

Identifier Type: -

Identifier Source: org_study_id