Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer
1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
2. Patients with known germline BRCA1/2 mutations
3. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after
previous first line chemotherapy or progression after later lines of cytotoxic
4. 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)
5. Age ≥ 18 years.
6. Performance status 0-2.
7. Measurable disease by RECIST 1.1 or evaluable by CA125 GCIG criteria
8. Adequate bone marrow function, liver function, renal function and coagulation
parameters (within 7 days prior to randomization):
WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l Platelet count ≥ 100 x 10^9/l
Hemoglobin ≥ 9.7 g/dl (6 mmol/L) Serum bilirubin ≤ 1.5 x ULN Serum transaminases ≤
2.5 x ULN Serum creatinine ≤ 1.5 x ULN
9. Written informed consent.
10. Tissue available for BRCAness analysis.
1. Previous treatment with a PARP inhibitor.
2. Platinum-refractory disease (disease that progressed or was stable during prior
3. 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.
4. Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at
screening is mandatory.
5. Fertile patients not willing to use acceptable and safe methods of contraception
during and for 6 months after treatment
6. Other present or previous malignancy except curatively treated cervical cancer stage
I, non-melanotic skin cancer or other cancer with minimal risk of relapse.
Curatively treated prior breast cancer is allowed if no relapse is suspected at time
7. CNS metastasis.
8. 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).
9. Allergy to the ingredients of the study medication.