Study on Relacorilant with Nab-paclitaxel and Bevacizumab for Advanced Ovarian, Peritoneal, or Fallopian-Tube Cancer
Sponsor: Corcept Therapeutics
ClinicalTrials ID:NCT06906341
This clinical trial is testing a new combination of drugs, including relacorilant, nab-paclitaxel, and bevacizumab, to see if they are safe and effective in treating advanced ovarian, peritoneal, or fallopian-tube cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment combination for patients with advanced ovarian, primary peritoneal, or fallopian-tube cancer. The treatment includes relacorilant, nab-paclitaxel, and bevacizumab, and is given in cycles. Patients will continue treatment until their cancer progresses, they experience severe side effects, or meet other criteria for stopping treatment. The study will monitor how well the treatment works and its safety.
Description
In this study, patients will receive a combination of three drugs: relacorilant, nab-paclitaxel, and bevacizumab. The treatment starts on the first day of each 28-day cycle. Relacorilant is taken by mouth for three days in a row, starting the day before receiving nab-paclitaxel, which is given through an IV on specific days of the cycle. Bevacizumab is also given through an IV every two weeks. Patients will continue with this treatment until their cancer worsens, they experience side effects that cannot be managed, or they meet other criteria to stop. The study will closely monitor the effectiveness and safety of this treatment combination.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian-tube cancer.
- Cancer that has not responded to platinum-based treatments within 183 days.
- At least one tumor that can be measured by scans.
- Expected to live at least 3 more months.
- Good overall health with an ECOG performance status of 0 or 1.
- Able to swallow pills and not have severe nausea or vomiting.
- Have had 1 to 3 previous treatments for ovarian cancer, including at least one platinum-based treatment.
- Previous treatment with bevacizumab is allowed.
- Adequate organ function based on specific blood test results.
- Negative pregnancy test for women who can become pregnant.
Exclusion Criteria
- Cancer progressed while on weekly paclitaxel or nab-paclitaxel for platinum-resistant ovarian cancer.
- Side effects from previous cancer treatments not resolved to mild levels.
- Recent surgery within 4 weeks before joining the study.
- Recent treatments with chemotherapy, immunotherapy, or other investigational drugs within a specific timeframe before starting the study.
- Recent radiation therapy or hormonal treatments within a specific timeframe before starting the study.
- Conditions requiring frequent steroid use.
- Current use of certain medications that affect the immune system.
- Severe nerve damage or high blood pressure.
- Uncontrolled medical conditions that could interfere with the study.
- Recent bowel obstruction or fluid buildup in the abdomen or chest.
- Non-healing wounds or recent abdominal issues.
- Use of blood thinners or clot-dissolving medications shortly before starting the study.
- Active infections like HIV, hepatitis B, or C.
- Untreated or symptomatic brain metastases.
- History of other cancers within the last 3 years.
- Recent live vaccinations.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| 292 | 97102 | Albuquerque | New Mexico |
| 304 | 45459 | Centerville | Ohio |
| 517 | 97401 | Eugene | Oregon |
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