Active not recruitingPHASE3INTERVENTIONAL

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

This clinical trial is for women with advanced ovarian, fallopian tube, or primary peritoneal cancer that is considered 'platinum-resistant,' meaning previous platinum-based chemotherapy didn't stop the cancer for long. The study aims to see if adding an experimental drug called relacorilant to a standard chemotherapy drug, nab-paclitaxel, is more effective than nab-paclitaxel alone. Researchers will compare how long patients live and how long it takes for the cancer to get worse. This is particularly for patients who have already tried several other treatments. The goal is to find a better treatment option that could help without causing more side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Corcept Therapeutics

Enrolment target

381

Start

29 Jun 2022

Estimated completion

01 Mar 2026

Ovarian Neoplasm Fallopian Tube Neoplasms Peritoneal Neoplasms

What is this study about?

This study is a clinical trial looking into new ways to treat advanced ovarian, fallopian tube, or primary peritoneal cancer. These types of cancer are often treated with chemotherapy drugs containing platinum. However, sometimes the cancer comes back or continues to grow within six months of having platinum-based treatment. This is what doctors call 'platinum-resistant' cancer.

For patients who have already had many other treatments, finding effective new options can be challenging. This trial is specifically designed for these patients. It compares a new approach: using a drug called relacorilant alongside a standard chemotherapy drug, nab-paclitaxel, versus using nab-paclitaxel by itself.

The main goals of the study are to see if the combination treatment helps patients live longer and if it takes longer for their cancer to worsen compared to nab-paclitaxel alone. Researchers are hopeful that this combination could offer a better way forward for patients with this type of cancer without increasing unwanted side effects. Participating means helping doctors understand more about how to treat these serious conditions.

Key takeaways

This study is for advanced ovarian, fallopian tube, or peritoneal cancer that has not responded well to previous platinum-based chemotherapy.
It tests a new drug combination: relacorilant with nab-paclitaxel, versus nab-paclitaxel alone.
The aim is to find out if the new combination can help patients live longer or keep cancer from worsening for longer.
It's for patients who have already had several different cancer treatments.
All participants receive close medical supervision and care.

Who may be eligible?

To be considered for this study, you would need to have a confirmed diagnosis of advanced ovarian, primary peritoneal, or fallopian tube cancer that doctors have identified as 'high-grade' (meaning it tends to grow more quickly). Your cancer must also be considered 'platinum-resistant,' which means it progressed within six months of your last platinum-containing chemotherapy.

You should have already received between one and three different types of cancer treatments, including one platinum-based therapy and a drug called bevacizumab. You also need to be well enough to take part, meaning you can carry out most of your daily activities, and your organs (like your liver and kidneys) are working well. You must be able to swallow medication, and if you can get pregnant, you'll need to use reliable birth control.

There are also some reasons you might not be able to join. For example, if you have significant ongoing side effects from previous treatments or certain other medical conditions. The study is open to women aged 18 and older.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have high-grade ovarian, fallopian tube, or primary peritoneal cancer?
Has my cancer progressed within 6 months of platinum chemotherapy?
Have I had between 1 and 3 previous treatments for my cancer, including bevacizumab?
Am I generally well enough to do most daily activities (ECOG 0 or 1)?
Am I able to swallow medicine by mouth?
If I can get pregnant, am I willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either a combination of relacorilant and nab-paclitaxel, or nab-paclitaxel on its own. The specific dose and how often you get the treatment will be planned by the study doctors. You will continue to receive the study treatment for as long as it is helping your cancer and you are not experiencing significant side effects.

Throughout the study, you will have regular visits with the study team. These visits will involve blood tests, physical examinations, and scans to monitor your cancer and check for any side effects. You will also need to provide past tissue samples of your cancer, or have a new small biopsy if older samples aren't available.

Even after you stop taking the study medication, if your cancer progresses or if side effects become too severe, the study team will continue to follow up with you to track your overall health and survival. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment that might be more effective than current options, especially when standard treatments haven't worked well. You will also receive careful medical monitoring and contribute to advancing medical knowledge that could help future patients. However, there are also potential risks; the experimental drug or combination might not work for you, or it could cause unexpected or unpleasant side effects. You might also have more doctor visits and tests than usual. You are free to withdraw from the study at any time and for any reason, without it affecting your future medical care.

Locations (117)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Site 318
Verified postcode
Phoenix, United States
Site 277
Verified postcode
Tucson, United States
Site 350
Verified postcode
Irvine, United States
Site 364
Verified postcode
La Jolla, United States
Site 150
Verified postcode
Palo Alto, United States
Site 278
Verified postcode
San Francisco, United States
Site 014
Verified postcode
San Francisco, United States
Site 316
Verified postcode
Solvang, United States
Site 032
Verified postcode
Aurora, United States
Site 335
Verified postcode
Miami Beach, United States
Site 042
Verified postcode
Weston, United States
Site 009
Verified postcode
Atlanta, United States

Common questions

What does 'platinum-resistant' mean?

It means your cancer has started to grow again or did not shrink within six months after you finished treatment with chemotherapy drugs that contain platinum.

What kind of cancer is this study for?

This study is for advanced ovarian, primary peritoneal, or fallopian tube cancer that is high-grade and platinum-resistant.

What are the treatments in this study?

One group will receive a combination of a new drug called relacorilant and a chemotherapy drug called nab-paclitaxel. The other group will receive nab-paclitaxel alone.

Will I know which treatment I'm receiving?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment you are getting until the study is over, or in certain situations.

If I join, how long will I be on the treatment?

You will continue treatment for as long as it is helping your cancer and you are not having severe side effects. You will also be followed up afterwards.