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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
Cooper Institute for Reproductive Hormonal Disorders
Melrose Park, Pennsylvania, United States
Overall Survival
defined as the time from first dose of study drug to the date of death
Time frame: through study completion, an average of 16 months
A. Improvement in Quality of Life (QoL)
Participants complete QoL questionnaire EROTC QLQ-C30 every 8 weeks
Time frame: 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.
B. Improvement in Quality of Life (QoL)
Participants complete QoL questionnaire EROTC QLQ-LC13 (specific to lung cancer)
Time frame: 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.
Progression free survival
defined as the time from first dose of study drug to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause
Time frame: median of 15 weeks from study enrollment until end of study or the date of first documented progression, assessed every 12 weeks by radiologic examination,assessed up to 56 months.
Overall response rate
defined as the number of subjects whose best confirmed objective response is either a complete response (CR) or partial response (PR) divided by the number of randomized subjects
Time frame: assessed every 4 weeks, from date of enrollment until end of study or the date of death from any cause, assessed up to 56 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
to determine any toxicity from the drug at the 300 mg dosage.
Time frame: assessed every week for 1 month and then every 4 weeks, from date of enrollment until end of study or the date of death from any cause, assessed up to 56 months.
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