Study Comparing Avutometinib and Defactinib with Other Treatments for Patients with Recurrent Low-Grade Serous Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying a type of ovarian cancer known as Recurrent Low-Grade Serous Ovarian Cancer (LGSOC). The study will explore the effects of a combination treatment using two medications, Avutometinib and Defactinib, compared to other treatments chosen by doctors. The goal is to see how well these treatments work in preventing the cancer from getting worse.

Participants in the study will receive either the combination of Avutometinib and Defactinib or one of the other treatments, which may include medications like pegylated liposomal doxorubicin, paclitaxel, topotecan, letrozole, or anastrozole. These treatments are commonly used for this type of cancer. The study will involve regular visits to the clinic for treatment and monitoring over a period of time.

The purpose of this study is to compare the effectiveness of the combination treatment with the other available options. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatments affect the cancer. This research aims to provide valuable insights into better treatment options for patients with Recurrent Low-Grade Serous Ovarian Cancer.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving the combination therapy of avutometinib and defactinib, and the other receiving a treatment chosen by the investigator from a list of approved options.

2 treatment administration

If assigned to the combination therapy group, the patient will take avutometinib and defactinib orally. The specific dosage and frequency will be determined by the study protocol.

If assigned to the investigator’s choice group, the patient may receive one of the following treatments: pegylated liposomal doxorubicin (infusion), paclitaxel (infusion), topotecan (infusion), letrozole (oral tablet), or anastrozole (oral tablet). The dosage and frequency will depend on the specific medication and the patient’s medical history.

3 monitoring and assessments

Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular visits for physical examinations, blood tests, and imaging studies to assess the progression of the disease.

The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse.

4 end of treatment

The treatment will continue until the disease progresses, unacceptable side effects occur, or the patient decides to withdraw from the study.

After the treatment ends, follow-up visits may be scheduled to monitor the patient’s health and gather additional data on overall survival and other outcomes.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have recovered from any side effects of previous treatments, except for hair loss or low thyroid function.
  • If able to have children, must have a negative pregnancy test before starting the study.
  • If able to have children, must agree to use a reliable form of birth control during the study and for 30 days after the last treatment.
  • Must be willing to attend all scheduled visits, follow the treatment plan, and complete all tests and procedures required by the study.
  • Must have a confirmed diagnosis of Low-Grade Serous Ovarian Cancer (LGSOC), which can include cancer in the ovaries, fallopian tubes, or the lining of the abdomen.
  • Must be suitable for treatment with at least one of the following: pegylated liposomal doxorubicin, paclitaxel, topotecan, letrozole, or anastrozole, based on medical history and previous treatments.
  • Must have experienced a return or worsening of LGSOC after at least one round of platinum-based chemotherapy.
  • Must have normal organ function, as shown by specific blood tests and other health checks.
  • Must have a normal heart rhythm, with a QTc interval of 460 milliseconds or less, unless there is a specific heart condition.
  • Must have a documented KRAS gene status, which is determined by a specific test on tumor tissue.
  • Must have at least one tumor that can be measured according to specific guidelines.
  • Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) cannot participate.
  • Only female patients are eligible; male patients cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
IRCCS Humanitas Research Hospital Rozzano Italy
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH Essen Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Universitaetsklinikum Mannheim GmbH Mannheim Germany
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Aalborg University Hospital Aalborg Denmark
Netherlands Cancer Institute Amsterdam The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Ivdcubgj Rsthtsfw Dl Cujdff Dr Mcieoqvfzml Montpellier France
Cdjzwo Lrkd Bdybor Lyon France
Uxwdtxbghv Mgvckoz Cvbele Hxzcnpekqeblphaua Hamburg Germany
Iajvoz Isiooeoy Fkkayqvymtajw Ogubvwscjen Rome Italy
Icuyidqk Rlizgzlzs Phy Le Ssevpw Dvu Tfhfyb Dkti Agwyqow Iikv Sdekpr Meldola Italy
Ayrzrsx Oncbidbtbdh Pow Lzivmucegirgahutx Cjnlppeozf Catania Italy
Buzvdled Ubeuswxosv Hlvamdrm Cytbdw Besançon France
Hgbcdzhd Uykakifgppkee Duwwhpdq Donostia / San Sebastian Spain
Utbogolzcxdzvd Cahunpw Kbqdfzirv Gdansk Poland
Uclsbraufe Oh Astwget Edegem Belgium
Hhujvgji Vvrw dlodmewf Barcelona Spain
Ccscke Oxmau Lsltpdw Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
28.06.2024
Denmark Denmark
Recruiting
28.06.2024
France France
Recruiting
28.06.2024
Germany Germany
Recruiting
28.06.2024
Ireland Ireland
Recruiting
28.06.2024
Italy Italy
Recruiting
28.06.2024
Poland Poland
Recruiting
28.06.2024
Spain Spain
Recruiting
28.06.2024
The Netherlands The Netherlands
Recruiting
28.06.2024

Trial locations

Avutometinib is a medication being studied for its potential to treat recurrent low-grade serous ovarian cancer. It is used in combination with another drug to see if it can help stop the cancer from growing or spreading.

Defactinib is another medication used in this study alongside avutometinib. It is being tested to determine if it can enhance the effectiveness of the treatment for patients with recurrent low-grade serous ovarian cancer.

Investigated diseases:

Recurrent Low-Grade Serous Ovarian Cancer – This is a type of ovarian cancer characterized by the recurrence of cancerous cells in the ovaries, which are of a low-grade serous type. It typically grows slowly and is less aggressive compared to high-grade serous ovarian cancer. The disease often presents with symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. Over time, the cancer may spread to nearby tissues and organs within the pelvic region. The progression of this cancer can vary, with periods of stability followed by potential growth or spread. It is important to monitor the disease regularly to assess its progression.

Trial ID:
2023-508204-38-00
Protocol code:
VS-6766-301
NCT ID:
NCT06072781
Trial Phase:
Therapeutic confirmatory (Phase III)

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