Alpelisib + Olaparib for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+113 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing whether a combination of two drugs, alpelisib and olaparib, is more effective than standard chemotherapy for women with a specific type of ovarian cancer that doesn't respond well to usual treatments. Alpelisib works by stopping cancer cells from growing, while olaparib makes it harder for them to repair themselves. Olaparib has shown effectiveness in treating ovarian cancer, particularly in patients with certain genetic backgrounds.

Eligibility Criteria

This trial is for patients with high-grade serous ovarian cancer resistant to platinum therapy, without a BRCA mutation. They must have had 1-3 prior treatments and not be candidates for further platinum-based therapy. Participants need measurable disease or assessable CA-125 levels, good organ function, and an ECOG status of 0 or 1.

Inclusion Criteria

I have been diagnosed with a specific type of ovarian, fallopian tube, or peritoneal cancer.

My bone marrow and organs are functioning well.

My cancer can be tracked using a specific blood test for CA-125.

+5 more

Exclusion Criteria

You are currently using other treatments for cancer.

My liver is not working well (Child Pugh B or C).

I have a blockage or other serious problem in my intestines.

+5 more

Participant Groups

The study tests the effectiveness and safety of combining alpelisib with olaparib versus standard single-agent chemotherapy in treating high-grade serous ovarian cancer that's unresponsive to platinum treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: Alpelisib+olaparibExperimental Treatment2 Interventions

Alpelisib 200 mg orally once daily and olaparib 200 mg orally twice daily on a continuous dosing schedule.

Group II: Paclitaxel or PLDActive Control2 Interventions

Investigator's choice of one of 2 single agent cytotoxic chemotherapies: Paclitaxel 80 mg/m2 intravenously weekly or Pegylated liposomal Doxorubicin (PLD) 40-50 mg/m2 (physician discretion) intravenously every 28 days.

Alpelisib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Piqray for:

Hormone receptor-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

🇪🇺 Approved in European Union as Piqray for: