Relacorilant + Nab-Paclitaxel for Ovarian Cancer
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop all current medications, but you cannot take certain medications like strong CYP3A inhibitors or inducers, hormonal anticancer therapies within 7 days of the study, or systemic corticosteroids within 21 days of the study. It's best to discuss your current medications with the study team to see if any need to be adjusted.
What data supports the effectiveness of the drug Relacorilant + Nab-Paclitaxel for ovarian cancer?
Research shows that nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has been effective in treating various cancers, including breast and lung cancer, and has shown improved progression-free survival in breast cancer. Additionally, nab-paclitaxel combined with carboplatin has been evaluated for ovarian cancer, suggesting potential effectiveness in this context.12345
Is the combination of Relacorilant and Nab-Paclitaxel generally safe for humans?
Nab-Paclitaxel, also known as Abraxane, has been used safely in humans for various cancers, including breast and lung cancer. It is a formulation designed to reduce certain toxicities, and while some patients experience mild to moderate side effects like sensory neuropathies (nerve damage causing tingling or numbness), it is generally well-tolerated. There is no specific safety data available for the combination with Relacorilant, but Nab-Paclitaxel itself has a known safety profile.12356
What makes the drug Relacorilant + Nab-Paclitaxel unique for ovarian cancer?
The drug Relacorilant + Nab-Paclitaxel is unique because it combines a novel formulation of paclitaxel, which is bound to albumin nanoparticles, with Relacorilant, potentially enhancing the drug's effectiveness and reducing side effects. This combination is particularly promising for ovarian cancer, where treatment options are limited, and nab-paclitaxel has shown improved efficacy in other cancers.23578
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nab-paclitaxel with or without relacorilant in 28-day cycles until confirmed progressive disease or unacceptable toxicity
Follow-up
Participants are monitored for progression-free survival and overall survival after treatment
Treatment Details
Interventions
- Nab-paclitaxel
- Relacorilant
Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corcept Therapeutics
Lead Sponsor
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