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Topoisomerase I inhibitor

Veliparib + Topotecan for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Led By Andrea E Wahner Hendrickson

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

Ability to swallow and absorb the medication

PHASE II: All patients enrolled in the Phase II portion of this trial must have a history of biopsy-proven ovarian, fallopian tube or primary peritoneal cancer

Must not have

Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy

Prior treatment with a PARP inhibitor or topotecan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying veliparib and topotecan hydrochloride to treat patients with solid tumors, ovarian cancer that has come back or does not respond to treatment, or primary peritoneal cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems. Veliparib might also cause digestive issues and could affect kidney function.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow and absorb medication properly.

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I have a confirmed diagnosis of ovarian, fallopian tube, or primary peritoneal cancer.

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I've had less than 3 treatments and my cancer returned within a year after platinum-based therapy.

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I have an advanced cancer that cannot be surgically removed and no standard treatment can cure or significantly extend my life.

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I have a tumor that can be measured and is at least 2 cm in size, or 1 cm if measured by CT scan.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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

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I have previously been treated with a PARP inhibitor or topotecan.

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I haven't had a heart attack in the last 6 months, don't need ongoing heart failure treatment, and haven't had more than 2 chemotherapy treatments for my current cancer.

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I have no active cancer except for non-dangerous skin cancer or early cervical cancer.

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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)

Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors

Secondary study objectives

Adverse Events, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Duration of Response

Overall Survival

+2 more

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 (veliparib and topotecan hydrochloride)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topotecan Hydrochloride

2013

Completed Phase 3

~6270

Veliparib

2012

Completed Phase 3

~4780