Study of catequentinib (AL3818) combined with platinum chemotherapy for patients with recurrent or metastatic ovarian, fallopian tube, or primary peritoneal cancer

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What is this study about?

This clinical trial studies the effectiveness of adding catequentinib (also known as AL3818) to standard platinum-based chemotherapy in treating platinum-resistant recurrent or metastatic ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Catequentinib is a type of drug called a receptor tyrosine kinase inhibitor, which works by blocking certain proteins that help cancer cells grow.

The main purpose of this research is to determine if adding catequentinib to standard chemotherapy improves how long patients live without their cancer getting worse. The medication is taken by mouth in the form of capsules, with different dose levels being tested. During the study, participants will receive either catequentinib combined with standard chemotherapy or standard chemotherapy alone.

The study will track how well tumors respond to treatment, how long any improvements last, and how long patients survive overall. Doctors will use special imaging tests called CT or MRI scans to measure if tumors are shrinking or growing. The total duration of treatment may continue for up to 336 days, depending on how well patients respond and tolerate the medication.

1 Initial evaluation

A medical assessment will be performed to confirm your eligibility for the study

Tests will include CT or MRI scan to measure your condition

Basic health checks will evaluate your bone marrow, kidney, and liver function

2 Treatment assignment

You will be randomly assigned to one of two treatment groups

Group 1: catequentinib dihydrochloride capsules combined with standard chemotherapy

Group 2: standard chemotherapy alone

3 Treatment period

The medication will be taken by mouth in capsule form

Regular medical check-ups will monitor your health status

Imaging scans will be performed to track changes in your condition

Treatment continues until signs of disease progression or other stopping criteria

4 Follow-up evaluations

Regular assessments will track your response to treatment

Imaging scans will be reviewed by independent medical experts

Your overall health status will be monitored throughout the study period

The study is expected to continue until February 2025

5 Safety monitoring

Your health will be closely monitored throughout the study

Regular blood tests will check your body functions

Any side effects or health changes should be reported to the study team

Who Can Join the Study?

Must be a female aged 18 years or older
Must have a confirmed diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that is either:
- Platinum-resistant (cancer that progressed within 6 months after platinum chemotherapy) with at least two prior treatments
- Platinum-refractory (cancer that progressed during first platinum chemotherapy) with at least one prior treatment
Must have measurable cancer that can be seen on CT or MRI scan
Must have a life expectancy of at least 3 months
Must be able to take medications by mouth
Must have adequate:
- Blood cell counts
- Kidney function
- Liver function
- Blood clotting function
Must have good physical ability (ECOG performance status of 2 or better, meaning able to care for self but unable to work)
If able to become pregnant, must:
- Use birth control starting 1 week before treatment until 4 weeks after last treatment
- Have a negative pregnancy test within 28 days before starting
Must provide written informed consent
Must be willing and able to follow all study requirements and follow-up procedures

Who Cannot Join the Study?

History of allergic reactions to similar medications used in the study
Active brain metastases (cancer that has spread to the brain) that are not treated or stable
Significant heart problems including:
- Uncontrolled high blood pressure
- Heart attack within the past 6 months
- Unstable heart rhythm problems
Severe liver or kidney problems
Active bleeding or high risk of bleeding complications
Current participation in other clinical trials or treatment with experimental drugs within the past 30 days
Major surgery within the past 4 weeks
Pregnant or breastfeeding women
Unable to swallow oral medications
Active, uncontrolled infections requiring treatment
Any other serious medical condition that could interfere with study participation or interpretation of results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ijpmuamg Ruryiqprf Pco Lw Smkvap Dvt Tgzsvc Dpgr Ardnslt Ihmi Sdlbog	Meldola	Italy
Aoakpnl Oqrfirtvcpy Pnl Lurzffwalwawctmfp Czicjqbcjz	Catania	Italy
Alfblyb Uvpth Shqcuutmb Luqqaf Dr Bbidqdl	Bologna	Italy
Itmbvvvj Chjaaj Dcninvuyvegxpuhdt	L'hospitalet De Llobregat	Spain
Hjzvgjwh Vzuo dacpcoto	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.03.2022
Spain	Not recruiting	01.03.2022

Trial locations

Investigated drugs:

Catequentinib Dihydrochloride

Anlotinib (also known as AL3818 or Catequentinib) is a medication that works by blocking specific proteins called tyrosine kinases. These proteins are involved in cancer cell growth and survival. The medication is designed to help stop or slow down the growth of cancer cells when used together with standard chemotherapy treatments.

Platinum-based chemotherapy is a standard type of cancer treatment that uses platinum-containing drugs to kill cancer cells. This type of chemotherapy is commonly used to treat various types of cancers, including endometrial, ovarian, fallopian tube, and cervical cancers. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.

Ovarian Cancer – A disease that begins in the ovaries, which are the female reproductive organs that produce eggs. The cancer cells can grow and multiply uncontrollably, forming tumors in the ovaries. Over time, cancer cells can spread to the fallopian tubes, peritoneum (the lining of the abdomen), and other parts of the body. When cancer returns after initial treatment, it is called recurrent ovarian cancer.

Fallopian Tube Cancer – A rare cancer that develops in the fallopian tubes, which are the ducts that connect the ovaries to the uterus. The cancer begins when cells in the fallopian tubes start to grow abnormally and form tumors. These cancer cells can spread to nearby organs and other parts of the body.

Primary Peritoneal Cancer – A cancer that develops in the peritoneum, which is the thin layer of tissue that lines the abdomen and covers most organs in the abdominal cavity. The cancer cells grow and multiply in the peritoneal lining, forming tumors. This type of cancer behaves similarly to ovarian cancer and can spread throughout the abdominal cavity.

Trial ID:

2024-516166-11-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of catequentinib (AL3818) combined with platinum chemotherapy for patients with recurrent or metastatic ovarian, fallopian tube, or primary peritoneal cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?