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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months from enrollment of the last patient
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months from enrollment of the last patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months from enrollment of the last patient
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,020 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
Eligibility Criteria:
This trial includes the following eligibility 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.I can take pills and don't have uncontrollable vomiting.I have an active infection with HIV, hepatitis B, or hepatitis C.My cancer got worse within 6 months after finishing platinum-based therapy.I have not had major surgery in the last 4 weeks.My ovarian tumor is of a specific type, such as low-grade or clear cell.I have received a COVID-19 vaccine as recommended.I do not have any health conditions that could affect my safety or participation in the trial.I have a confirmed high-grade cancer in my ovary, peritoneum, or fallopian tube.My blood and organ tests show I am healthy enough for treatment.I have had cancer other than my current one in the last 3 years.I agree to provide samples of my tumor for the study.You are expected to live for at least 3 months.I am fully active or can carry out light work.I have not received a live vaccine in the last 30 days.I have never been treated with bevacizumab.I've had 1-3 cancer treatments, including platinum and bevacizumab.I've had extensive radiation therapy affecting over 25% of my bone marrow.I have mild or no nerve damage symptoms.I have brain metastases that are either untreated or causing symptoms.Side effects from my previous treatments are mild or gone.I regularly take oral corticosteroids for a health condition.I am on medication that strongly affects liver enzyme CYP3A activity.You must have at least one visible and measurable tumor according to specific guidelines.My side effects from previous cancer treatments are mild or gone.I am currently taking mifepristone or similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg
- Group 2: Nab-paclitaxel 100 mg/m^2
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Relacorilant 150 mg QD been cleared by the FDA?
"Relacorilant 150 mg once daily (QD) is estimated to be a 3 on a scale of 1-3 for safety. This is due to it being a Phase 3 trial, meaning that not only does some data support its efficacy, but multiple rounds also support its safety."
Answered by AI
What is the ambition of this clinical trial?
"The primary outcome of this trial is progression-free survival as assessed by BICR, which will be measured over a 24-month period. Secondary outcomes include duration of response as assessed by BICR (defined as the time from when response is first documented to first objectively documented PD or death, whichever occurs first), objective response as assessed by BICR (defined as the proportion of patients with measurable disease at baseline who attain CR or PR by RECIST v1.1.), and PFS as assessed by the investigator (defined as the time from randomization until the time of first documented progressive disease by RECIST v1"
Answered by AI
Is there space for new participants in this experiment?
"Yes, this is an active clinical trial that was posted on 6/29/2022 and last updated on 7/13/2022. They are currently enrolling 360 patients from 1 site."
Answered by AI
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