Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: Relacorilant with nab-paclitaxel

• Registration Number: NCT02762981
• Lead Sponsor: Corcept Therapeutics

Brief Summary

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.

Detailed Description

The study consisted of two segments to evaluate alternative dosing schedules of relacorilant administered at escalating dose levels. Segment I was to evaluate a continuous-dosing regimen and Segment II was to evaluate an intermittent-dosing regimen. Enrollment in Segment I and Segment II were mutually exclusive, and the two segments enrolled participants concurrently.

In Segment I continuous-dosing cohorts, participants received a single nab-paclitaxel lead-in infusion on Day 1 of Week -2 before Cycle 1, and oral relacorilant lead-in once-daily of Week -1 before Cycle 1. After the Data Review Committee review of data for 2 dose levels, the nab-paclitaxel lead-in was discontinued. The lead-in period was followed by oral relacorilant administered continuously once daily, in combination with nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment 1 enrolled a total of 64 participants.

In Segment II intermittent-dosing cohorts, participants received a single relacorilant lead-in dose on Day -1 before Cycle 1, followed by oral relacorilant, administered intermittently the day before, the day of, and the day after nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment II enrolled a total of 21 participants.

Study Timeline

• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2016-05-23
• Primary Completion: 2020-05-12
• Study Completion: 2020-09-12
• Results First Submitted: 2022-07-28
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Results First Posted: 2022-12-06
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relacorilant with nab-paclitaxel	Relacorilant with nab-paclitaxel	Participants will be treated with relacorilant in combination with nab-paclitaxel at escalating dose levels in either a Continuous-Dosing Regimen or an Intermittent-Dosing Regimen.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose-limiting Toxicity	Up to completion of Cycle 1 (up to 28 days)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	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)	Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Trial Locations

Locations (4)

014; 🇺🇸 San Francisco, California, United States

038; 🇺🇸 Scottsdale, Arizona, United States

001; 🇺🇸 Chicago, Illinois, United States

013; 🇺🇸 Ogden, Utah, United States