M10-897 A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects with Brain Metastases from Non-Small Cell Lung Cancer

Summary

This is a randomized Phase 2 double-blind, dose-ranging, multicenter, multinational study evaluating the safety and efficacy of veliparib when given during WBRT in subjects with brain metastases from nSCLC. The study will consist of a Treatment Period and a 24-month Long-term Follow-up Period. additionally, survival and post-treatment therapy information will be collected for up to 36 months.

Participant Eligibility


* Subject must be >= 18 years of age;

* Subject must have cytologically or histologically confirmed NSCLC;

* Subject must have brain metastases demonstrated on a MRI brain scan;CT scan of brain with or without contrast can be obtained if a subject is medically ineligible for MRI;

* Subject must be eligible for treatment with WBRT;

* Subject must have adequate hematologic, renal, and hepatic function as follows:
o Absolute Neutrophil Count (ANC > 1,000/mm3 [1.0 x 109/L]);
o Platelets > 100,000/mm3 (100 x 109/L);
o Hemoglobin > 9.0 g/dL (1.4 mmol/L);
o Serum creatinine < 1.5 x upper normal limit (ULN) OR creatinine clearance
> 45 mL/min/1.73m2 for subjects with creatinine levels above the ULN;
o AST and/or ALT < 2.5 x the ULN;
o Bilirubin < 1.5 x the ULN. Subjects with Gilbert's Syndrome may have a bilirubin
>= 1.5 x the ULN.

* Women of childbearing potential and men must agree to use adequate contraception prior to
study entry (sufficiently long enough to ensure prevention of pregnancy) for the duration of
study participation and for a minimum of 90 days following completion of therapy. Women of
childbearing potential must have a negative serum pregnancy test prior to initiation of treatment.
To be considered of non-child bearing potential, postmenopausal women must be amenorrheic
for at least 12 months or subjects must be surgically sterile. Adequate means of contraception
are considered to be:
o Total abstinence from sexual intercourse as the preferred life style, periodic abstinence is
not acceptable;
o Vasectomized male subjects or vasectomized partner of female subjects; a vasectomized
partner of female subjects must be an exclusive partner;
o Hormonal contraceptives (oral, vaginal ring, parenteral or transdermal);
o Double-barrier method (condoms and diaphragm or vaginal cap plus spermicidal sponge,
jellies or cream);
o Intra-Uterine Device (IUD).

* Note: Additionally, male subjects (including those who are vasectomized) with partners of
childbearing potential, must agree to use condoms for the duration of the Treatment Period and
for 90 days following completion of therapy.

* Subject must be able to take oral medication.

* 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.