Study on Alpelisib and Olaparib for Treating Platinum-resistant High-grade Serous Ovarian Cancer Without BRCA Mutation

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04729387

Provider View

This clinical trial is testing a combination of two drugs, alpelisib and olaparib, to see if they are more effective and safer than standard chemotherapy for women with high-grade serous ovarian cancer that has not responded to platinum-based treatments and does not have a BRCA mutation.

Patient Parameters

Program Overview

The aim of this study is to evaluate how well the combination of alpelisib and olaparib works compared to standard chemotherapy in women with high-grade serous ovarian cancer that is resistant to or has returned after platinum-based treatments, and who do not have a BRCA mutation. The study will also assess the safety of this drug combination.

Description

This study involves adult women with high-grade serous ovarian cancer that has not responded to or has returned after platinum-based treatments, and who do not have a BRCA mutation. Participants will be randomly assigned to receive either the combination of alpelisib and olaparib or standard chemotherapy (paclitaxel or PLD). The study is open-label, meaning both the participants and the researchers know which treatment is being given.

Participants will continue their assigned treatment until their cancer progresses, they experience unacceptable side effects, or they choose to stop for any other reason. After stopping treatment, participants will have a follow-up visit to check on their safety and another visit nine weeks later to assess their condition. After these visits, participants will enter a period where their survival will be monitored.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • Have at least one tumor that can be measured by scans or tests.
  • No BRCA1/2 mutation as confirmed by an approved test.
  • In good overall health with a performance status of 0 or 1.
  • Cancer that has not responded to platinum-based treatments or has returned shortly after such treatments.
  • Have received one to three previous treatment regimens and are suitable for single-agent chemotherapy.
  • Have received bevacizumab before or cannot receive it for medical reasons.

Exclusion Criteria

  • Have previously been treated with PI3K, mTOR, or AKT inhibitors.
  • Currently using other cancer treatments.
  • Have bowel obstruction or other serious digestive issues.
  • Have had surgery within the last 14 days or have not recovered from surgery.
  • Have not recovered from side effects of previous cancer treatments, except for hair loss.
  • Have uncontrolled diabetes or certain liver conditions.
  • Have received recent radiation therapy and have not recovered from its side effects.
  • Have allergies to any of the study drugs.
  • Have a history of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.

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