Clinical Trial Details
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NCT01657799 : A Clinical Study Conducted in Multiple Centers Comparing Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Subjects With Brain Metastases From Non Small Cell Lung Cancer (NSCLC)
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Subject must be greater than or equal to 18 years of age

- Subject must have cytologically or histologically confirmed non-small cell lung

- Subject must have brain metastases demonstrated on a MRI brain scan

- Subject must be eligible for WBRT

Exclusion Criteria:

- Subject is diagnosed with brain metastases greater than 28 days prior to treatment

- Subject received any prior form of cranial radiation and/or neurosurgery for their
brain metastases

- Subject's last dose of anti-cancer therapy or investigational therapy was less than
or equal to 7 days prior to treatment

- Subject has a Karnofsky Performance Score of less than 70

- Subject has significant dyspnea requiring supplemental oxygen therapy

- Subject has liver metastases (restaging is not required for known liver metastases)

- Subject has more than 2 sites (organ systems) of metastases from non-small cell lung
cancer with the exception of intra-cranial sites of metastases from non-small cell
lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone

- Subject has leptomeningeal metastases or subarachnoid spread of tumor

- Subject has unresolved or unstable, serious toxicity from prior administration of
another investigational drug and/or prior anti-cancer treatment

- Subject has a known seizure disorder that is uncontrolled, or has seizures occurring
greater than or equal to 3 times a week over the past month. Subjects presenting with
symptoms of seizures from the brain metastases are eligible; however he/she should
receive adequate anti-seizure medication prior to study treatment

- Subject is pregnant or lactating

- Subject has previously been treated with a poly-(ADP-ribose)-polymerase inhibitor as
an investigational agent

- Subject has clinically significant and uncontrolled major medical condition(s)

- Subject has a history of another active cancer within the past 5 years except:
cervical cancer in situ, in situ carcinoma of the bladder, basal or squamous cell
carcinoma of the skin or other cancer in situ that is considered cured
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