Evaluating the Safety and Tolerability of the Poly-ADP Ribose (PARP) Inhibitor With FOLFIRI in Subjects With Solid Tumor

Inclusion Criteria

• •1. Subject must be at least 18 years of age.
• •2. Subjects in the dose escalation cohorts must have: \* Subjects with histologically or cytologically confirmed malignancy that is meta static or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective or for whom treatment with FOLFIRI is a viable option.
• •3. Subjects in the expanded safety cohort must have: \* Histological confirmed advanced colorectal cancer.
• •4. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
• •5. Subject must have adequate hematologic, renal and hepatic function as follows: \* Bone Marrow: Absolute neutrophil count ANC \>= 1,500/mm3; Platelets \>= 100,000/mm3; Hemoglobin \>= 9.5 g/dL; \* Renal function: Serum creatinine \< 1.5 \* upper normal limit of institution's normal range OR creatinine clearance \<= 50 mL/min/1.73m2 for subjects with creatinine levels above institutional normal; \* Hepatic function: AST and ALT \<= 2.5 \* the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT \<= 5 \* the upper normal limit of institution's normal range; \* Bilirubin \<= 1.5 \* the upper normal limit of institution's normal range;
• •6. Partial Thromboplastin Time (PTT) must be \<= 1.5 \* the upper normal limit of institution's normal range and INR \< 1.5. Subjects on anticoagulant (such as Coumadin) will have PTT and INR as determined by the investigator.
• •7. 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 21 days prior to initiation of treatment 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 of female subjects; \* 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 (Intra-Uterine Device); \* Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completions of therapy.
• •8. Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
• •9. The subject has received up to 3 prior DNA damaging agents or cytotoxic chemotherapy treatments (prior therapies with biologic agents including, IL -2, interferon, vaccines, immunostimulants and signal transduction inhibitors are allowed) Chemotherapy received as adjuvant therapy before 2 years will not be considered as prior chemotherapy.