Comparing Platinum-based Therapy with TSR-042 and Niraparib to Standard Treatment for Advanced Ovarian Cancer

Sponsor: Tesaro, Inc.

Sponsor score: 40

ClinicalTrials ID:NCT03602859

This study is testing a new combination of drugs, including TSR-042 and Niraparib, with standard chemotherapy to see if it works better than the usual treatment for women with advanced ovarian cancer.

Patient Parameters

Program Overview

This clinical trial is exploring whether adding the drugs TSR-042 and Niraparib to the standard chemotherapy treatment can improve outcomes for women with advanced stage III or IV non-mucinous epithelial ovarian cancer. The study will compare how long patients live without the cancer getting worse when treated with this new combination versus the standard treatment. The standard treatment usually includes chemotherapy drugs paclitaxel and carboplatin, sometimes with bevacizumab. Participants will start with the standard treatment before being randomly assigned to receive either the new combination or continue with the standard treatment.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older who understand and agree to participate in the study.
  • Diagnosed with high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer at stage III or IV.
  • Eligible if they have stage IV disease or meet specific criteria for stage III.
  • Must provide blood and tumor samples for specific genetic testing.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 180 days after the last treatment.
  • Must have good organ function and be in generally good health with controlled blood pressure.
  • Must agree to complete quality of life questionnaires and be able to take oral medication.

Exclusion Criteria

  • Have a different type of ovarian cancer, such as mucinous or low-grade tumors.
  • Have not fully recovered from major surgery.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have active brain cancer or significant heart disease.
  • Have bowel obstructions or certain serious abdominal conditions.
  • Have a history of certain blood disorders or have had another invasive cancer within the last 5 years.
  • Have a high risk of bleeding or are immunocompromised.
  • Have active hepatitis B or C infections.
  • Have received other investigational treatments recently or have allergies to study drugs.
  • Have an active autoimmune disease requiring treatment in the past 2 years.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site99508AnchorageAlaska
GSK Investigational Site85016PhoenixArizona
GSK Investigational Site85711TucsonArizona
GSK Investigational Site90027Los AngelesCalifornia
GSK Investigational Site90048Los AngelesCalifornia
GSK Investigational Site92663Newport BeachCalifornia
GSK Investigational Site06030FarmingtonConnecticut
GSK Investigational Site06102HartfordConnecticut
GSK Investigational Site32608GainesvilleFlorida
GSK Investigational Site32256JacksonvilleFlorida

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