CompletedPhase 2NCT02666105

Exemestane in Post-Menopausal Women With NSCLC

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).

Checked against the public recordLast updated May 31, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations18
SponsorMasonic Cancer Center, University of Minnesota
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Masonic Cancer Center, University of Minnesota
Interventions being studied
Drug: Exemestane
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic Health SystemAlbert Lea, Minnesota
  • Essentia Health St. Joseph's Medical CenterBrainerd, Minnesota
  • Essentia Health Deer RiverDeer River, Minnesota
  • Essentia Health St. Mary's Detroit LakesDetroit Lakes, Minnesota
  • Essentia Health Cancer CenterDuluth, Minnesota
  • Essentia Health FosstonFosston, Minnesota
  • Fairview Grand Itasca Clinic & HospitalGrand Rapids, Minnesota
  • Essentia Health HibbingHibbing, Minnesota
  • Fairview Range Medical CenterHibbing, Minnesota
  • Mayo Clinic Health SystemMankato, Minnesota
  • Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota
  • Monticello Cancer Center (MMCORC)Monticello, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 31, 2023. Always confirm current availability with the study team.

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