Peposertib + Chemotherapy for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byRachel N Grisham

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of peposertib when given together with pegylated liposomal doxorubicin hydrochloride in treating patients with high or low grade ovarian cancer that has come back after a period of improvement (recurrent). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin 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 peposertib and pegylated liposomal doxorubicin hydrochloride may work better in treating patients with ovarian cancer compared to pegylated liposomal doxorubicin hydrochloride alone.

Eligibility Criteria

This trial is for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Participants must have had at least one prior platinum-based chemotherapy and can be of any age above 18. They should not be pregnant or breastfeeding and must agree to use contraception. People with certain heart conditions, uncontrolled illnesses, or those unable to take oral medication are excluded.

Inclusion Criteria

I have chronic hepatitis B but it's under control with treatment.

Your total bilirubin level should be no more than 1.5 times the upper limit of normal at the medical facility where you are being treated.

I have another cancer type, but it won't affect this treatment's safety or results.

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Exclusion Criteria

Pregnant or breastfeeding women

Psychiatric illness/social situations that would limit compliance with study requirements

I have allergies to medications similar to peposertib or pegylated liposomal doxorubicin.

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Treatment Details

Interventions

Pegylated Liposomal Doxorubicin Hydrochloride (Anti-tumor antibiotic)
Peposertib (ATR Kinase Inhibitor)

Trial OverviewThe study is testing the combination of a new drug called Peposertib with standard chemotherapy (pegylated liposomal doxorubicin hydrochloride) against ovarian cancer that has returned after treatment. The goal is to find out if this combo is more effective than the standard chemo alone.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (peposertib, PLD)Experimental Treatment7 Interventions

Patients receive peposertib PO BID on days 1-21, days 1-28, or days 1-7 (depending on dose level) and pegylated liposomal doxorubicin hydrochloride IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI during screening and every 8 weeks and after 6 months of study treatment, every 12 weeks. Patients undergo ECHO during screening and every 6 months. Starting in cycle 13, patients undergo ECHO or MUGA scan every 2 cycles. Additionally, patients undergo blood sample collection throughout the study.

Pegylated Liposomal Doxorubicin Hydrochloride is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Doxil for: