An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.
1. Subject has completed study participation in Study M11-846
2. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
3. Subject must have adequate hematologic, renal and hepatic function per institutional
normal range as follows: • Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3
(1.5 × 109/L); Platelets ≥ 100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.5 g/dL (1.4
mmol/L); • Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) range
OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above
institutional normal; • Hepatic function: AST and ALT ≤ 2.5 × the ULN range. For
subjects with liver metastases, AST and ALT < 5 × the ULN range; Bilirubin ≤ 1.5 ×
the ULN range. • Partial Thromboplastin Time (PTT) must be ≤ 1.5 × the ULN range and
INR < 1.5. Subjects on anticoagulant therapy (such as Coumadin) will have an
appropriate PTT and INR as determined by the Investigator.
4. Women of childbearing potential must agree to use adequate contraception (one of the
following listed below) prior to study entry, for the duration of study participation
and for 90 days following completion of therapy. Women of childbearing potential must
have a negative serum pregnancy test within 28 days prior to initiation of treatment
and a negative urine pregnancy test on Cycle 1 Day 1 and/or post menopausal women
must be amenorrheic for at least 12 months to be considered of non-childbearing
potential. • Total abstinence from sexual intercourse (minimum one complete menstrual
cycle); • Vasectomized partner; • Hormonal contraceptives (oral, parenteral or
transdermal) for at least 3 months prior to study drug administration; •
Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with
spermicidal jellies or cream); • IUD (Intrauterine Device).
1. Subject has received anticancer agent(s) or an investigational agent (except for
veliparib) within 28 days prior to study drug administration. Subjects who have not
recovered to within one grade level (not to exceed grade 2) of their baseline
following a significant adverse event or toxicity attributed to previous anticancer
treatment are excluded.
2. Subject has undergone major surgery within the previous 28 days prior to study drug
3. Subject has received radiotherapy within 28 days prior to study drug administration.
4. Clinically significant and uncontrolled major medical condition(s) including but not
limited to: • Active uncontrolled infection; • Symptomatic congestive heart failure;•
Unstable angina pectoris or cardiac arrhythmia; • Psychiatric illness/social
situation that would limit compliance with study requirements; • Any medical
condition, which in the opinion of the Study Investigator, places the subject at an
unacceptably high risk for toxicities.
5. Subject is pregnant or lactating.