Study of Relacorilant and Nab-Paclitaxel for Patients with Advanced, Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. The study is testing a new treatment that combines two medications: relacorilant and nab-paclitaxel. Relacorilant is also known by its code name CORT125134. Nab-paclitaxel is a form of chemotherapy that is often used to treat various types of cancer. The purpose of this study is to compare the effectiveness of the combination of relacorilant and nab-paclitaxel against nab-paclitaxel alone in treating this type of cancer.

Participants in the study will receive either the combination of relacorilant and nab-paclitaxel or nab-paclitaxel by itself. The treatment will be given over a period of 28 days, and the study will monitor how the cancer responds to the treatment. The study aims to see if the combination treatment can help control the cancer better than nab-paclitaxel alone. The study will also look at how long patients live without the cancer getting worse and other measures of how well the treatment works.

This trial is important for understanding if adding relacorilant to nab-paclitaxel can provide a new option for patients with this challenging type of cancer. The study will help determine if the combination treatment can improve outcomes for patients compared to the standard treatment with nab-paclitaxel alone. Participants will be closely monitored throughout the study to ensure their safety and to gather important information about the treatment’s effects.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving a combination of relacorilant and nab-paclitaxel, and the other receiving nab-paclitaxel alone.

The patient will be required to provide informed consent and may need to provide a tumor tissue sample if available.

2 treatment phase

Patients in the combination group will take relacorilant orally in the form of soft capsules. The specific dosage and frequency will be determined by the study protocol.

All patients will receive nab-paclitaxel intravenously. This medication is administered as a dispersion for infusion, with the dosage and schedule specified by the study protocol.

3 monitoring and assessments

Throughout the study, patients will undergo regular assessments to monitor their health and the effectiveness of the treatment.

These assessments may include imaging tests to measure disease progression, blood tests, and other evaluations as required by the study protocol.

4 end of treatment

The treatment phase will continue until the patient experiences disease progression, unacceptable side effects, or chooses to withdraw from the study.

The study is expected to conclude by December 31, 2025, but individual participation may end earlier based on the patient’s condition and response to treatment.

5 follow-up

After completing the treatment phase, patients will enter a follow-up period where their health will continue to be monitored.

The follow-up will help gather additional data on the long-term effects and outcomes of the treatment.

Who Can Join the Study?

You must sign and date a form that shows you agree to participate in the study.
You need to agree to provide a sample of your tumor tissue, if available. If not, you may agree to a new biopsy.
You should have a life expectancy of at least 3 months.
You must have at least one tumor that can be measured, according to specific guidelines. Tumors that were treated with radiation before cannot be used unless they have grown again.
Your overall health should be good, as measured by a specific scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1.
You should be able to follow the study’s requirements.
You must be able to swallow pills and should not have uncontrolled vomiting.
You should have received at least 1 but no more than 3 previous treatments for cancer. You must have tried at least one treatment with a drug containing platinum and a drug called bevacizumab.
Your organs should be working well, according to specific lab tests.
If you can have children, you must have a negative pregnancy test and agree to use effective birth control methods. Hormonal birth control is not allowed.
You can receive COVID-19 vaccines if recommended by the study doctor, unless it interferes with the study.
You must be a female aged 18 years or older.
You need to have a confirmed diagnosis of a specific type of cancer, which includes high-grade ovarian, primary peritoneal, or fallopian tube cancer.
Your cancer must be resistant to platinum treatment, meaning it worsened less than 6 months after finishing a platinum-based therapy.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who are not female cannot participate.
Patients who are under the age of 18 or over the age of 65 cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Grand Hopital De Charleroi	Charleroi	Belgium
Ospedale Mater Salutis Di Legnago	Legnago	Italy
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
University Of Debrecen	Debrecen	Hungary
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Jessa Ziekenhuis	Hasselt	Belgium
Hopital Prive Des Cotes D’armor	Plerin	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Immobiliere De Nancy	Nancy	France
Cvxtvajdw Uezpeuvelirtfc Snouunihp	Woluwe-Saint-Lambert	Belgium
Igryzhxl Rxzudpma Df Chzaep Di Mexzzlqjdcp	Montpellier	France
Snvyvvvr Pbsrziqgu Szk z omcw	Gdynia	Poland
Ogjhzvpnlkbyxutcgqtgutieju	Aalst	Belgium
Uaeaaqnzdzhrt Slkjlng Kxmxesbev Nn 2 Pin W Sdzzsdgbum	Szczecin	Poland
Aqvukar Oxbtiajnfzi Pgx Lpjdgcnricqapyxdw Cbwwfvbzaz	Catania	Italy
Gykthitevtgeugvpw Vxpugaowl Pppc Avfuay Ebejwgpf Oadotf Kueiru	Gyor	Hungary
Hkuwzuif Ubxsxgjkywwaf Dmessmmw	Donostia / San Sebastian	Spain
Unjjcbincw Dlwrx Skhyu Dn Rxhv Ld Soylcziu	Rome	Italy
Icsqetmd Cusfid Dskqjxwqhcrjkmnyt	L'hospitalet De Llobregat	Spain
Hauuqsrh Vgbv denmjfrj	Barcelona	Spain
Cyrvkn Ohtyw Ltcdstv	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.05.2023
France	Not recruiting	08.05.2023
Hungary	Not recruiting	08.05.2023
Italy	Not recruiting	08.05.2023
Poland	Not recruiting	08.05.2023
Spain	Not recruiting	08.05.2023

Trial locations

Investigated drugs:

Relacorilant is a medication being studied for its potential to enhance the effectiveness of cancer treatment. In this trial, it is used in combination with another drug to see if it can help improve outcomes for patients with certain types of advanced cancer.

Nab-Paclitaxel is a chemotherapy drug used to treat various types of cancer. It works by stopping the growth of cancer cells. In this study, it is used both alone and in combination with relacorilant to compare the effectiveness of the treatments.

Investigated diseases:

Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian Cancer – This is a type of ovarian cancer that has become resistant to platinum-based chemotherapy, which is a common treatment for ovarian cancer. It is characterized by the presence of high-grade cancer cells that originate from the epithelial cells lining the ovaries. The disease often progresses rapidly and can spread to other parts of the body, including the abdomen and pelvis. Symptoms may include abdominal pain, bloating, and changes in bowel habits. The cancer is considered advanced when it has spread beyond the ovaries to other areas.

Primary Peritoneal Cancer – This cancer originates in the peritoneum, a thin layer of tissue lining the abdomen and covering the uterus, bladder, and rectum. It is similar to epithelial ovarian cancer in terms of symptoms, progression, and treatment. The disease can cause abdominal swelling, pain, and digestive issues as it progresses. It often spreads within the abdominal cavity and can affect nearby organs. The cancer is considered advanced when it has spread beyond the peritoneum.

Fallopian-Tube Cancer – This rare cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It shares many characteristics with ovarian cancer, including symptoms like pelvic pain and abnormal vaginal bleeding. The disease can progress by spreading to nearby organs and tissues within the pelvis and abdomen. It is often diagnosed at an advanced stage due to its subtle symptoms. The cancer is considered advanced when it has spread beyond the fallopian tubes.

Trial ID:

2024-514080-25-00

Protocol code:

CORT125134-556

NCT ID:

NCT05257408

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Relacorilant and Nab-Paclitaxel for Patients with Advanced, Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?