Relacorilant + Nab-Paclitaxel for Ovarian Cancer

Recruiting at 117 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Corcept Therapeutics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new combination of two drugs for ovarian cancer patients who have no other treatment options left. The combination includes a drug that may make chemotherapy more effective and a chemotherapy drug that has been used in various cancer treatments. The goal is to see if this combination can help patients live longer without their disease getting worse.

Research Team

Sachin Pai, MD

Principal Investigator

Corcept Therapeutics

Eligibility Criteria

This trial is for patients with advanced, platinum-resistant high-grade ovarian, primary peritoneal, or fallopian tube cancer. Participants must have had 1-3 prior cancer treatments including platinum therapy and bevacizumab. They should not have unresolved severe side effects from past treatments, no major surgery within the last month, and no untreated brain metastases.

Inclusion Criteria

Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures

Negative pregnancy test for patients of childbearing potential; patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed

Able to comply with protocol requirements

Exclusion Criteria

My cancer did not improve or got worse within 1 month after my first platinum-based chemotherapy.

You are currently receiving treatment for ovarian, fallopian tube, or primary peritoneal cancer in another research study.

I haven't had certain cancer treatments in the weeks before starting the study drug.

Treatment Details

Interventions

• Nab-paclitaxel (Anti-tumor antibiotic)
• Relacorilant (Corticosteroid)

Trial Overview The study tests relacorilant combined with nab-paclitaxel against nab-paclitaxel alone to see which is better at slowing down cancer progression. Patients will either receive relacorilant daily with intermittent doses of nab-paclitaxel or just regular doses of nab-paclitaxel.

Participant Groups

Group I: Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg Experimental Treatment 2 Interventions

Patients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1.

Group II: Nab-paclitaxel 100 mg/m^2 Active Control 1 Intervention

Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.

Nab-paclitaxel is already approved in Canada for the following indications:

Approved in Canada as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Gynecologic Oncology Group

Collaborator

Trials

251

Recruited

65,400+