Relacorilant + Nab-Paclitaxel for Ovarian Cancer

Recruiting at 117 trial locations

Overseen By Sachin Pai, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Corcept Therapeutics

Must not be taking: Corticosteroids, Mifepristone, CYP3A modulators

Disqualifiers: HIV, Hepatitis, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 24 months

381 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{2 3 5 7 8}

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

Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures

Negative pregnancy test for patients of childbearing potential; patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed

Able to comply with protocol requirements

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nab-paclitaxel with or without relacorilant in 28-day cycles until confirmed progressive disease or unacceptable toxicity

Up to 24 months

Visits on Days 1, 8, and 15 of each 28-day cycle

Follow-up

Participants are monitored for progression-free survival and overall survival after treatment

Up to 24 months

Treatment Details

Interventions

• Nab-paclitaxel
• Relacorilant

Trial Overview 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.

Participant Groups

Group I: Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg Experimental Treatment 2 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^2 Active Control 1 Intervention

Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.

Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Approved in European Union as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Approved in Canada as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

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

Trials

251

Recruited

65,400+

Findings from Research

Nab-paclitaxel, a new formulation of paclitaxel, has shown a good safety and efficacy profile for treating metastatic breast cancer (MBC), although there is limited data on its impact on overall survival.

In combination with gemcitabine, nab-paclitaxel significantly improves survival in advanced pancreatic cancer (PC) and demonstrates better results in non-small-cell lung cancer (NSCLC) patients with squamous histology, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy evaluation of albumin-bound paclitaxel. Cecco, S., Aliberti, M., Baldo, P., et al.[2015]

NAB-paclitaxel at a dose of 125 mg/m² was well tolerated in patients with stage IV non-small-cell lung cancer, with no hypersensitivity reactions reported and a maximum-tolerated dose established without significant dose-limiting toxicities.

The treatment showed promising efficacy, with a 30% objective response rate, a median time to progression of 5 months, and a median overall survival of 11 months, indicating its potential as a viable single-agent therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer. Rizvi, NA., Riely, GJ., Azzoli, CG., et al.[2015]

Nab-paclitaxel was well tolerated in pediatric solid tumor models, with a maximum weight loss of about 10% that returned to baseline after treatment, indicating a favorable safety profile.

The treatment showed significant efficacy, improving event-free survival in 19 out of 20 solid tumor xenograft models, particularly demonstrating high activity against Ewing sarcoma and rhabdomyosarcoma, making it a promising candidate for further pediatric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). Houghton, PJ., Kurmasheva, RT., Kolb, EA., et al.[2022]

Nab-PTX (Abraxane®) was administered to 31 breast cancer patients without any allergic reactions, indicating it is well tolerated, even in those with alcohol intolerance.

Among patients with locally advanced operable breast cancer, higher doses (260 mg/m²) resulted in a better response rate, with 10 out of 13 showing a partial response, suggesting its efficacy in treating advanced stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of nab-Paclitaxel treatment in 31 patients with breast cancer]. Tauchi, Y., Kashiwagi, S., Ishihara, S., et al.[2015]

In a study of 47 patients with recurrent ovarian, peritoneal, or fallopian tube cancer, nab-paclitaxel demonstrated a significant objective response rate of 64%, indicating its efficacy in this patient population.

The treatment was associated with manageable toxicities, primarily neutropenia (24%) and neuropathy (9%), suggesting that nab-paclitaxel could be a viable option for patients with limited therapeutic choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer. Teneriello, MG., Tseng, PC., Crozier, M., et al.[2015]

Nab-paclitaxel, a nanoparticle albumin-bound form of paclitaxel, is the first nanotechnology-based drug approved for cancer treatment, showing significant promise in breast and pancreatic cancers.

This innovative drug not only enhances the effectiveness and reduces the toxicity of traditional treatments but also demonstrates activity in cancers that typically do not respond to standard taxane therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nanoparticle albumin bound Paclitaxel in the treatment of human cancer: nanodelivery reaches prime-time? Cucinotto, I., Fiorillo, L., Gualtieri, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy evaluation of albumin-bound paclitaxel. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer. [2015]

3. Japan pubmed.ncbi.nlm.nih.gov

A phase II, multicenter, single-arm study of tri-weekly low-dose nanoparticle albumin-bound paclitaxel chemotherapy for patients with metastatic or recurrent breast cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy evaluation of albumin-bound paclitaxel combined with carboplatin as neoadjuvant chemotherapy for primary epithelial ovarian cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

[Clinical experience of nab-Paclitaxel treatment in 31 patients with breast cancer]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer. [2015]

8. Egypt pubmed.ncbi.nlm.nih.gov

Nanoparticle albumin bound Paclitaxel in the treatment of human cancer: nanodelivery reaches prime-time? [2022]