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 :
Terminated
(Lack of enrollment)
First Posted : December 30, 2015
Last Update Posted : October 19, 2020
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | December 11, 2015 | ||||||||||||
First Posted Date ICMJE | December 30, 2015 | ||||||||||||
Last Update Posted Date | October 19, 2020 | ||||||||||||
Actual Study Start Date ICMJE | December 2015 | ||||||||||||
Actual Primary Completion Date | October 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer | ||||||||||||
Official Title ICMJE | 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 | ||||||||||||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer (NSCLC) | ||||||||||||
Intervention ICMJE | 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.
Other Name: KORLYM®, C1073, CORLUXIN™ and CORLUX™.
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Study Arms ICMJE | Experimental: mifepristone
mifepristone 300 mg capsule per day, orally in 28-day cycles
Intervention: Drug: Mifepristone
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||
Actual Enrollment ICMJE |
3 | ||||||||||||
Original Estimated Enrollment ICMJE |
40 | ||||||||||||
Actual Study Completion Date ICMJE | October 15, 2020 | ||||||||||||
Actual Primary Completion Date | October 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Each patient must meet the following criteria to be enrolled in the study
Exclusion Criteria: Patients who meet any of the following criteria will not be permitted entry to the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT02642939 | ||||||||||||
Other Study ID Numbers ICMJE | MIF-01-2014 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Check, Jerome H., M.D., Ph.D. | ||||||||||||
Study Sponsor ICMJE | Check, Jerome H., M.D., Ph.D. | ||||||||||||
Collaborators ICMJE | Corcept Therapeutics | ||||||||||||
Investigators ICMJE |
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PRS Account | Check, Jerome H., M.D., Ph.D. | ||||||||||||
Verification Date | October 2020 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |