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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
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.
Details
| Lead sponsor | Check, Jerome H., M.D., Ph.D. |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 3 |
| Start date | 2015-12 |
| Completion | 2020-10-15 |
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
- Mifepristone
Primary outcomes
- Overall Survival — through study completion, an average of 16 months
defined as the time from first dose of study drug to the date of death - A. Improvement in Quality of Life (QoL) — every 8 weeks from date of enrollment until end of study or the date of death from any cause, assessed using QoL questionnaire,assessed up to 56 months.
Participants complete QoL questionnaire EROTC QLQ-C30 every 8 weeks - B. Improvement in Quality of Life (QoL) — every 8 weeks from date of enrollment until end of study or the date of death from any cause, assessed using QoL questionnaire,assessed up to 56 months.
Participants complete QoL questionnaire EROTC QLQ-LC13 (specific to lung cancer)
Countries
United States