Veliparib + Topotecan for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen by Andrea E. Wahner Hendrickson, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of veliparib and topotecan hydrochloride and to see how well they work in treating patients with solid tumors, ovarian cancer that has come back or does not respond to treatment, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib with chemotherapy may kill more tumor cells.

Research Team

Andrea E. Wahner Hendrickson, M.D.

Principal Investigator

Mayo Clinic Cancer Center LAO

Eligibility Criteria

This trial is for adults with certain advanced cancers, including ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that have returned or are resistant to treatment. Participants must have measurable disease and should not have had more than two prior chemotherapy regimens. They need to be able to swallow medication and provide blood and urine samples as required by the study.

Inclusion Criteria

I can swallow and absorb medication properly.

Willingness to provide biologic specimens as required by the protocol

Negative urine or serum pregnancy test for females of childbearing potential only

Exclusion Criteria

Specific medical conditions such as New York Heart Association classification III or IV, known CNS metastases, pregnancy, nursing, unwillingness to use contraception, co-morbid systemic illnesses, immunocompromised status, receiving other investigational agents

I have recently had treatments like chemotherapy or radiation.

There is a known treatment that could cure or extend my life.

Treatment Details

Interventions

• Topotecan Hydrochloride (Topoisomerase I inhibitor)
• Veliparib (PARP Inhibitor)

Trial Overview The trial is testing the combination of Veliparib, which may block enzymes needed for tumor growth, with Topotecan Hydrochloride, a chemotherapy drug that kills or stops tumor cells from growing. The aim is to find the best dose of Veliparib and see how well it works alongside chemotherapy in treating these cancers.

Participant Groups

Group I: Treatment (veliparib and topotecan hydrochloride) Experimental Treatment 5 Interventions

Patients receive veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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