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

Exclusion Criteria

• •1. Prior treatment with a PARP inhibitor.
• •2. Patients with BRCA1/2 germline mutation.
• •3. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
• •4. 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.
• •5. Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory.
• •6. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
• •7. 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.
• •8. CNS metastasis.
• •9. History of any chronic medical or psychiatric condition or laboratory abnormality, which 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).
• •10. Allergy to the ingredients of the study medication.