Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02642939|
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : August 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer (NSCLC)||Drug: Mifepristone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
mifepristone 300 mg capsule per day, orally in 28-day cycles
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.
Other Name: KORLYM®, C1073, CORLUXIN™ and CORLUX™.
- Overall Survival [ Time Frame: 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) [ 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. ]Participants complete QoL questionnaire EROTC QLQ-C30 every 8 weeks
- B. Improvement in Quality of Life (QoL) [ 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. ]Participants complete QoL questionnaire EROTC QLQ-LC13 (specific to lung cancer)
- Progression free survival [ 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. ]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
- Overall response rate [ 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. ]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
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ 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. ]to determine any toxicity from the drug at the 300 mg dosage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642939
|Contact: Diane L Check, BSMTfirstname.lastname@example.org|
|United States, Pennsylvania|
|Cooper Institute for Reproductive Hormonal Disorders||Recruiting|
|Melrose Park, Pennsylvania, United States, 19027|
|Contact: Diane L Check, BSMT 215-635-6621 email@example.com|
|Principal Investigator: Jerome H Check, MD, PhD|
|Principal Investigator:||Jerome H Check, MD,PhD||Cooper Institute for Reproductive Hormonal Disorders|