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Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

NCT02642939 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-10-19

No results posted yet for this study

Summary

This is a non-randomized, multicenter, single-stage phase II study of mifepristone in patients with advanced or metastatic NSCLC who have failed two or more previous chemotherapy regimens.

The Investigator plans to enroll 18 evaluable patients in Stage 1, and additionally up to 22 evaluable patients in Stage 2 for a total of 40 evaluable patients. Participants will be followed for overall survival. Current salvage therapy in advanced NSCLC achieves a median progression free survival time of 10 weeks and overall survival of 10 months. The Investigator would like to provide evidence that mifepristone will increase the median progression-free survival time to 15 weeks and overall survival time of 16 months.

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Mifepristone

Mifepristone is an antagonist of the GR-II (glucocorticoid) receptor, yet has little affinity for the GR-I (mineralocorticoid) receptor. Mifepristone is also a potent antagonist at the progesterone receptor, and may block the androgen receptor to a limited degree.

Sponsors & Collaborators

  • Corcept Therapeutics

    collaborator INDUSTRY

  • Check, Jerome H., M.D., Ph.D.

    lead INDIV

Principal Investigators

  • Jerome H Check, MD,PhD · Cooper Institute for Reproductive Hormonal Disorders

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-10-15
Completion
2020-10-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642939 on ClinicalTrials.gov