CompletedPhase 1/2

Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status

Denmark22 participantsStarted 2012-11

Plain-language summary

The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
. Platinum resistance or partially platinum sensitive disease
. Age ≥ 18 years.
. Performance status 0-2.
. Measurable disease by RECIST 1.1 or CA125 GCIG criteria
. Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment):
. Written informed consent.

Exclusion criteria

. Prior treatment with a PARP inhibitor.
. Patients with BRCA1/2 germline mutation.
. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib

Timeframe: 1 month

Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status

Timeframe: Every three months, up to 3 years

Trial details

NCT IDNCT01690598

SponsorVejle Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Ovarian Cancer trials