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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Duration of Response

Overall Survival

+2 more

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

~6120

Veliparib

2012

Completed Phase 3

~4820

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,065 Total Patients Enrolled

Andrea E Wahner HendricksonPrincipal InvestigatorMayo Clinic Cancer Center LAO

3 Previous Clinical Trials

103 Total Patients Enrolled

Media Library

Topotecan Hydrochloride (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01012817 — Phase 1 & 2

Fallopian Tube Cancer Research Study Groups: Treatment (veliparib and topotecan hydrochloride)

Fallopian Tube Cancer Clinical Trial 2023: Topotecan Hydrochloride Highlights & Side Effects. Trial Name: NCT01012817 — Phase 1 & 2

Topotecan Hydrochloride (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01012817 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If this clinical trial is successful, could it be scaled up to help more patients?

"This study is still enrolling patients and has 15 sites across the United States of America. For example, there are participating clinics in Phoenix, Aurora, Jacksonville, and other cities. To limit travel as much as possible, please choose the closest location to you when enrolling."

Answered by AI

Are there any openings in this trial for participants?

"Unfortunately, this particular clinical trial is not currently recruiting patients. Although, it's worth noting that the last update to this study was on September 1st, 2022. If you're interested in other studies, 5558 trials for relapse are actively enrolling participants and 80 Pharmacological Studies are searching for patients right now."

Answered by AI

To date, how many people have enrolled in this clinical trial?

"This study is not currently looking for new participants. The posting date was October 29th, 2009 and the most recent update occurred on September 1st, 2029. If you are interested in other studies, 5558 trials for relapse patients and 80 Pharmacological Studies are actively recruiting."

Answered by AI

What other investigations have there been into the effects of this medication?

"The Pharmacological Study was first conducted in 2005 at St. Jude Children's Research Hospital. So far, 769 similar studies have been completed while 80 are still active. Currently, many of the active studies are taking place in Phoenix, Arizona."

Answered by AI

By the end of this research, what do investigators hope to have accomplished?

"The goal of this study is to find the maximum tolerated dose of topotecan hydrochloride and veliparib combination therapy, as determined by incidence of dose-limiting toxicity. The study will last for up to 48 weeks (12 courses), and secondary objectives include duration of response, progression free survival, and time to treatment failure."

Answered by AI