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

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Hrjczmfl Vhmz dumwjpgs Barcelona Spain
Innyguhg Rbdwrqiha Pku Lg Stlbzc Dji Tbamvl Dxjb Aumjhuk Ixty Sbsdsp Meldola Italy
Cqvftom Ucewsvskyvegaqhhqlfp Bbhhrv Kee Berlin Germany
Szjqmukcu Rtkndys Uqbcnlrzxi Mxrrgwr Cypuco Nijmegen The Netherlands
Ujeycmjntxtysoqlhaxkt Miltpgto Guwr Mannheim Germany
Uceonrykdo Cbubqutc Hhqycddn Vpmecb Dw Lo Ahyswhqm Murcia Spain
Unnhfhyvugzx Dc Szgythps Dl Cgvlsidrvr Santiago De Compostela Spain
Abofhkq Ushljqylhx Hffoyfts Aalborg Denmark
Udwwirdmpwdgki Czsfeot Ktgstlota Gdansk Poland
Cqjwfa Leri Bcohku Lyon France
Uybfxehwmg Op Agehcuj Edegem Belgium
Uabxwbdxjk Moawmsh Cmherd Hwdfjdjvpgbwanaqj Hamburg Germany
Iarolp Ieuhtvgl Fowmylosdrsqp Oudzxdlblhc Rome Italy
Cjrnwk hbynofsvknq ubgiatuwrbdnn dd Lgjzn Liege Belgium
Ilyqiiys flss Klnnxsvom Tvatjzpttiyhazjdyyy udv Ihhrhusaejrn Uaf gffyh Ulm Germany
Utojouwajewb Znrxddebdh Ghdw Gent Belgium
Uigskezhfy Dkaym Supcj Dn Bjbcpns Brescia Italy
Cquxjh Hxnmtfdhqxc Uwlgnglsexxxp Dvhcju Gkrbpgy Slsuqzxjaeprsxfldwptwbvjjo Namur Belgium
Fmubmufivm Iwhvquqhra Isazgafy Nbopysvhiqw Bbwbw Milan Italy
Ijuzsvgq Ojzxulunrt Vnmpey Padua Italy
Icezmzkb Rfiqomng Dx Clryma Dm Mpbrtuaexif Montpellier France
Cviqpf Oqpxs Lnzgdro Lille France
Atqrdkzncf Fpezpjolwtk Dajqmgch Kqfpxmey gnmvo Frankfurt Germany
Arhtbin Oqkgpwvlwew Pvi Lrgloizkcxcfmopxm Ctlweqssep Catania Italy
Kfuyvmyy Eioaq Szev Ebkfrrdkluhmr Kumgtnyqrvz Eowpnjpenilf geigi Essen Germany
Bjctuuli Uvdsmncyqv Hitqxujy Cyrjcp Besançon France
Hzyjqppo Uwjskwdegkzwa Dhezzxxy Donostia / San Sebastian Spain
Nrtpidzzahk Ctdkts Iixberujq Amsterdam The Netherlands
Alfmlzd Ojiiuzpvvtx Oibqem Mszrtopuhu Df Tttqpx Turin Italy
Bdrsdnvfqhas Chtrnfk Odlirssly Ide Mibhd Sqaoxpiclbllgkjvne W Bovowskzpla Bialystok Poland

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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