NCT02642939

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

A Phase II Study of Treatment With Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Two or More Previous Chemotherapy Regimens

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Check, Jerome H., M.D., Ph.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-randomized, multicenter, single-stage phase II study of mifepristone in patients with Stage IIIB or Stage IV NSCLC who have failed two or more previous chemotherapy regimens. The primary objective of this trial is to evaluate the utility of mifepristone as a salvage therapy in patients with Stage IIIB or Stage IV non-small cell lung carcinoma who have failed at least two previous chemotherapy regimens. Efficacy will be measured by improvement in progression-free survival and life span; and overall response as compared to historical controls. Plan to enroll 18 evaluable patients in Stage 1 and up to 22 evaluable patients in Stage 2 for a total of 40 evaluable patients. Anticipated duration of the study is approximately up to 36 months. Patients who tolerate treatment in the first cycle are eligible to continue to receive treatment until they experience unacceptable toxicity, until they meet any of the withdrawal criteria, or until the study is terminated by the Sponsor. Patient may continue treatment despite evidence of tumor progression if they feel better, i.e. improved quality of life.We will follow all patients 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. We 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

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2015-12-30
• Last updated: 2020-10-19

Locations

1 site across 1 country: United States