Solid Tumors Clinical Trial
Official title:
Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
Verified date | November 2022 |
Source | Corcept Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to assess the safety of the combination of relacorilant (CORT125134), a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in participants with solid tumors and to determine the preliminary efficacy of the combination of relacorilant and nab-paclitaxel. The structure for the study was a single arm, non-randomized, open- label, multicenter trial with no control group.
Status | Completed |
Enrollment | 85 |
Est. completion date | September 12, 2020 |
Est. primary completion date | May 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants with advanced or metastatic solid tumors who have disease progression after treatment with available therapies and for whom nab-paclitaxel treatment is appropriate. - Measurable or evaluable disease. - Up to 3 prior cytotoxic chemotherapeutics regimens or myelosuppressive therapies in the advanced setting. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - For Part 2 Only: Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, or Triple Negative Breast Cancer with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in at least 1 lesion, that in the opinion of the Investigator is appropriate to treat with nab-paclitaxel. Exclusion Criteria: - Any major surgery within 4 weeks prior to the first dose of study drug. - Some protocol specified treatments prior to the first dose of study drug. |
Country | Name | City | State |
---|---|---|---|
United States | 001 | Chicago | Illinois |
United States | 013 | Ogden | Utah |
United States | 014 | San Francisco | California |
United States | 038 | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Objective Response Rate | Objective response rate is defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as best response of complete response (CR) or partial response (PR) from the start of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses). | Up to 512 days | |
Other | Clinical Benefit Rate | Clinical benefit rate is defined as the participants who have achieved CR or PR (including both confirmed and unconfirmed responses), or stable disease for 16 weeks or greater. | Up to 512 days | |
Other | Duration of Response | Duration of response (DOR) is defined as the date that criteria are met for CR or PR until the first date that progressive disease or death is objectively documented, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment | From the time of response up to the last disease assessment (up to 512 days) | |
Other | Progression-free Survival | Progression-free survival is defined as the time from date of first dose of relacorilant or nab-paclitaxel, whichever is earliest, to the date of documented disease progression per RECIST v1.1 or death for any cause, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment. | Up to 512 days | |
Other | Overall Survival | Overall survival is defined as the time from date of the first dose of relacorilant or nab paclitaxel, whichever is earliest, to the date of death for any cause. Participants with no documentation of death on-study are censored at the date at which they are last known to be alive. | Up to 512 days | |
Other | Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level | Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses). | Up to 512 days | |
Other | Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 | ||
Other | Pharmacokinetics: AUC0-24 of Plasma Nab-Paclitaxel | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 | ||
Other | Pharmacokinetics: Maximum Concentration (Cmax) of Plasma Relacorilant | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 | ||
Other | Pharmacokinetics: Cmax of Plasma Nab-Paclitaxel | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 | ||
Primary | Number of Participants With Dose-limiting Toxicity | The Maximum Tolerated Dose and the development regimen of relacorilant with nab-paclitaxel was determined by the number of participants with dose-limiting toxicities as defined in the protocol. | Up to completion of Cycle 1 (up to 28 days) | |
Secondary | Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years) |
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