What side effects are associated with this type of intervention?

The most common treatments for Fallopian Tube Cancer, such as Nab-paclitaxel, are associated with side effects including neuropathy, neutropenia, fatigue, and gastrointestinal issues like diarrhea. When combined with other agents like gemcitabine, these side effects can be more pronounced. Platinum-based chemotherapies, commonly used in this cancer type, can cause nephrotoxicity, ototoxicity, and myelosuppression. Taxanes, including paclitaxel, may lead to neuropathy, myalgia, and infusion reactions, often necessitating steroid premedication.

What prior FDA approvals exist?

Nab-paclitaxel (Abraxane) has been FDA-approved for use in combination with other chemotherapeutic agents for the treatment of various cancers, including metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer. For ovarian, peritoneal, and fallopian tube cancers, treatments often involve combinations of platinum-based chemotherapies (e.g., carboplatin) with taxanes (e.g., paclitaxel or nab-paclitaxel). While Relacorilant, a selective glucocorticoid receptor modulator, is currently being studied in combination with nab-paclitaxel for advanced, platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer, it has not yet received FDA approval for this specific indication.

What other types of research exist?

Promising novel alternatives to Relacorilant in combination with Nab-paclitaxel for Fallopian Tube Cancer patients include: 1) Bevacizumab combined with chemotherapy (e.g., paclitaxel, pegylated liposomal doxorubicin, or topotecan) as shown in the AURELIA trial for platinum-resistant ovarian cancer. 2) Trabectedin plus pegylated liposomal doxorubicin, which has shown efficacy in recurrent ovarian cancer. 3) Eribulin, which has demonstrated improved overall survival in certain subtypes of soft tissue sarcoma and may be considered for similar applications in gynecologic cancers.

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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 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.

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.

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.

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 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival as Assessed by BICR

Secondary study objectives

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.

0 / 19Eligibility criteria met

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.