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 range18 Years

SexFEMALE

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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)
✕. Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.
✕. Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory.
✕. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
✕. Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse. Previous breast cancer is allowed, if disease free follow-up at least five years prior to enrollment.
✕. CNS metastasis.

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

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