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Anti-tumor antibiotic

Relacorilant + Nab-Paclitaxel for Ovarian Cancer

Phase 3
Waitlist Available
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow and retain oral medication and does not have uncontrolled emesis
Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression <6 months from completion of a platinum-containing therapy)
Must not have
Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤1 month of the last dose of first-line platinum-containing chemotherapy
Has current chronic/active infection with human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months from enrollment of the last patient
Awards & highlights

Summary

This trial is testing a new cancer drug combo vs. the old standard to see if the new one helps people live longer without their cancer progressing.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include nerve damage (neuropathy), allergic reactions to drugs used in the trial, blood disorders like low platelet count or anemia, liver issues indicated by abnormal enzyme levels in blood tests, and general symptoms such as fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and don't have uncontrollable vomiting.
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My cancer got worse within 6 months after finishing platinum-based therapy.
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I have a confirmed high-grade cancer in my ovary, peritoneum, or fallopian tube.
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My blood and organ tests show I am healthy enough for treatment.
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I am fully active or can carry out light work.
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I've had 1-3 cancer treatments, including platinum and bevacizumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer did not improve or got worse within 1 month after my first platinum-based chemotherapy.
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I have an active infection with HIV, hepatitis B, or hepatitis C.
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I have not had major surgery in the last 4 weeks.
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My ovarian tumor is of a specific type, such as low-grade or clear cell.
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I have had cancer other than my current one in the last 3 years.
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I have never been treated with bevacizumab.
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I've had extensive radiation therapy affecting over 25% of my bone marrow.
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I have mild or no nerve damage symptoms.
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I have brain metastases that are either untreated or causing symptoms.
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Side effects from my previous treatments are mild or gone.
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I am on medication that strongly affects liver enzyme CYP3A activity.
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My side effects from previous cancer treatments are mild or gone.
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I am currently taking mifepristone or similar medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months from enrollment of the last patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months from enrollment of the last patient for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival as Assessed by BICR
Secondary outcome measures
Best Overall Response as Assessed by BICR
CA-125 Antigen
Clinical benefit rate as assessed by BICR
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mgExperimental Treatment2 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^2Active Control1 Intervention
Patients receive nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Relacorilant, a selective glucocorticoid receptor modulator, blocks cortisol's effects, potentially reducing cancer cell survival and proliferation. Nab-paclitaxel, a microtubule stabilizer, inhibits cell division by preventing microtubule disassembly. These mechanisms are crucial for Fallopian Tube Cancer patients as they offer targeted approaches to hinder cancer growth, potentially improving treatment efficacy and reducing side effects.
Stathmin 1 is highly expressed and associated with survival outcome in malignant adrenocortical tumours.Licofelone Enhances the Efficacy of Paclitaxel in Ovarian Cancer by Reversing Drug Resistance and Tumor Stem-like Properties.In vitro evaluation of the effects of gefitinib on the cytotoxic activity of selected anticancer agents in a panel of human endometrial cancer cell lines.

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,040 Total Patients Enrolled
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
71,026 Total Patients Enrolled
Dorothy Nguyen, MDStudy DirectorCorcept Therapeutics
5 Previous Clinical Trials
241 Total Patients Enrolled

Media Library

Nab-paclitaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05257408 — Phase 3
Fallopian Tube Cancer Research Study Groups: Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg, Nab-paclitaxel 100 mg/m^2
Fallopian Tube Cancer Clinical Trial 2023: Nab-paclitaxel Highlights & Side Effects. Trial Name: NCT05257408 — Phase 3
Nab-paclitaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05257408 — Phase 3
~120 spots leftby Jul 2025