CompletedPhase 1/2

Veliparib Monotherapy for Relapsed Ovarian Cancer With BRCA Mutation

Denmark49 participantsStarted 2011-11

Plain-language summary

The main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.

Who can participate

Age range18 Years

SexFEMALE

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. Stages I-IV.
✓. Patients with known germline BRCA1/2 mutations
✓. 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 (Relapsed within six months of prior first line/later lines of platinum-based therapy or relapsed within six to twelve months of prior first line/later lines of platinum-based therapy)
✓. Age ≥ 18 years.
✓. Performance status 0-2.
✓. Measurable disease by RECIST 1.1 or evaluable by CA125 GCIG criteria
✓. Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):

Exclusion criteria

✕. Previous treatment with a PARP inhibitor.
✕. 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 regimen, or who have participated in another clinical trial within 28 days prior to entering this trial.
✕. Pregnant or breast-feeding patients. 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.
✕. CNS metastasis.
✕. History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease).

What they're measuring

Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose.

Timeframe: 6 months

Phase II: Response rate

Timeframe: Every 3 months

Trial details

NCT IDNCT01472783

SponsorVejle Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Recurrent, Epithelial Ovarian Cancer trials