Olaparib Maintenance Therapy for Ovarian Cancer

(SOLO-1 Trial)

Recruiting in Palo Alto (17 mi)

+176 other locations

Overseen by Kathleen Moore, M.D., MS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Research Team

Kathleen Moore, M.D., MS

Principal Investigator

University of Oklahoma Health Sciences Center, Oklahoma City, USA

Prof Paul DiSilvestro, MD

Principal Investigator

Women & Infants Hospital, Providence, Rhode Island, USA

Eligibility Criteria

This trial is for women with newly diagnosed high-grade ovarian cancer (FIGO stage III-IV) that have specific harmful mutations in BRCA genes. They should have responded well to first-line platinum-based chemotherapy and undergone debulking surgery if needed. Women with stable or worsening disease post-chemotherapy, early-stage cancer, multiple surgeries before the study, or previous chemo for abdominal tumors are excluded.

Inclusion Criteria

I've had surgery aimed at removing as much cancer as possible.

I have a harmful BRCA1 or BRCA2 mutation.

I am a woman with advanced ovarian, peritoneal, or fallopian tube cancer with a BRCA mutation and have finished first-line platinum chemotherapy.

Exclusion Criteria

I have early-stage endometrial cancer and am under 60, or I'm 60+ with a specific early cancer type.

My BRCA1/2 mutations are not harmful.

My cancer did not improve but also did not worsen after my first chemotherapy.

Treatment Details

Interventions

• Olaparib (PARP Inhibitor)

Trial Overview The trial tests Olaparib tablets as a maintenance therapy for patients who've had a positive response to initial chemotherapy. It's aimed at preventing cancer from coming back by targeting BRCA mutations which are common in high-grade ovarian cancers.

Participant Groups

Group I: Olaparib tablets p.o. 300mg twice daily Experimental Treatment 1 Intervention

Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

Group II: Placebo tablets p.o. twice daily Placebo Group 1 Intervention

Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Myriad Genetic Laboratories, Inc.

Industry Sponsor

Trials

32

Recruited

14,600+