Ovarian low malignant potential tumour Trials in Disease

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

This clinical trial is investigating whether adding catequentinib (also known as AL3818) to standard platinum-based chemotherapy can help patients with recurrent or metastatic ovarian, fallopian tube, or primary peritoneal cancer. Catequentinib is a type of targeted therapy called a receptor tyrosine kinase inhibitor, which works by blocking specific proteins that help cancer cells grow and form new blood vessels.

Main inclusion criteria:

• Female patients aged 18 years or older
• Confirmed diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that is either platinum-resistant (cancer that returned within 6 months after platinum chemotherapy) with at least two prior treatments, or platinum-refractory (cancer that progressed during first platinum chemotherapy) with at least one prior treatment
• Measurable cancer visible on CT or MRI scans
• Life expectancy of at least 3 months
• Adequate blood cell counts, kidney function, liver function, and blood clotting function
• Able to care for self but unable to work (ECOG performance status of 2 or better)
• If of childbearing potential, must use birth control and have a negative pregnancy test

Main exclusion criteria:

• History of allergic reactions to similar medications
• Active or untreated brain metastases
• Significant heart problems including uncontrolled high blood pressure, recent heart attack, or unstable heart rhythm
• Severe liver or kidney problems
• Active bleeding or high bleeding risk
• Major surgery within the past 4 weeks
• Pregnant or breastfeeding
• Unable to swallow oral medications
• Active, uncontrolled infections

Focus and goal of the trial:

The primary goal of this research is to determine if adding catequentinib to standard chemotherapy improves how long patients live without their cancer getting worse, known as progression-free survival. Participants will be randomly assigned to receive either catequentinib combined with standard chemotherapy or standard chemotherapy alone. The medication is taken by mouth in capsule form, with different dose levels being tested.

During the study, doctors will use CT or MRI scans to monitor whether tumors are shrinking or growing. The study will track how well tumors respond to treatment, how long any improvements last, and overall survival. Treatment may continue for up to 336 days, depending on how well patients respond and tolerate the medication. Regular medical check-ups, blood tests, and imaging scans will be performed throughout the treatment period to monitor health status and treatment response.

Investigational drugs:

The trial is testing two main treatments:

• Catequentinib (Anlotinib or AL3818): A targeted therapy that blocks specific proteins called tyrosine kinases, which are involved in cancer cell growth and blood vessel formation. By blocking these proteins, the drug aims to slow down or stop tumor growth.
• Platinum-based chemotherapy: A standard cancer treatment that uses platinum-containing drugs to damage the DNA of cancer cells, preventing them from dividing and growing.

Summary

Currently, there is one active clinical trial for patients with ovarian low malignant potential tumours and related conditions. This trial is being conducted in two European countries: Italy and Spain. The study focuses on evaluating catequentinib, a targeted therapy drug that blocks specific proteins involved in cancer growth, when combined with standard platinum-based chemotherapy.

This trial is specifically designed for patients whose cancer has returned or spread and has shown resistance to platinum chemotherapy. The research aims to determine whether adding this new targeted therapy to standard treatment can extend the time patients live without their disease worsening. Patients interested in participating should discuss their eligibility with their healthcare provider, as the trial has specific requirements regarding previous treatments, overall health status, and disease characteristics.