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Anti-tumor antibiotic

Peposertib + Chemotherapy for Ovarian Cancer

Phase 1

Waitlist Available

Led By Rachel N Grisham

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy, if indicated

Patients must have a cardiac ejection fraction >= the institutional lower limit of normal (LLN)

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to peposertib (M3814) or pegylated liposomal doxorubicin

Significant (uncontrolled) cardiac conduction abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing peposertib + pegylated liposomal doxorubicin hydrochloride to treat ovarian cancer. The combination may work better than doxorubicin hydrochloride alone.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include reactions related to Peposertib such as fatigue, nausea, and potential liver issues; plus typical chemo side effects like hair loss, mouth sores, low blood counts leading to increased infection risk, and heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My heart's pumping ability is within the normal range.

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I have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.

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I am 18 years old or older.

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I can take care of myself but might not be able to do active work.

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I have had platinum-based chemotherapy before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have serious heart rhythm problems that aren't under control.

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I do not have any uncontrolled illnesses or active infections.

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I have been treated with anthracyclines for ovarian cancer.

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I cannot stop taking my current medications or herbal supplements that may affect peposertib treatment.

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I cannot take pills by mouth.

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I am currently taking sorivudine or a similar drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Pharmacokinetics (PK) parameters of nedisertib

Other study objectives

Progression-free survival

Neoplasms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790