Olaparib for Advanced Cancer

Recruiting at54 trial locations

Overseen by Patricia M Lorusso

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well olaparib works in treating patients with glioma, cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that has spread from where it first started (primary site) to other places in the body (metastatic) and that does not respond to treatment (refractory). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Patricia M Lorusso

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

Adults with advanced glioma, cholangiocarcinoma, or solid tumors that have IDH1/IDH2 mutations and are treatment-resistant can join. They must meet certain health criteria like blood cell counts, organ function tests, agree to use contraception if applicable, and be willing to undergo biopsies. Those with recent major surgery, uncontrolled medical issues, HIV/hepatitis or a history of other cancers may not qualify.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

Leukocytes >= 3,000/mcL

Platelet count >= 100 x 10^9/L

Exclusion Criteria

I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

I do not have any serious, uncontrolled health issues or infections.

Treatment Details

Interventions

• Olaparib (PARP Inhibitor)

Trial Overview The trial is testing Olaparib's effectiveness on patients whose cancer has spread and doesn't respond to standard treatments. It involves taking the drug orally and monitoring its impact through various assessments including biopsies and imaging techniques like CT scans and MRIs.

Participant Groups

Group I: Treatment (olaparib) Experimental Treatment 5 Interventions

Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and/or MRI, as well as a tumor biopsy and blood sample collection on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School