Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2015-01-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy and safety of veliparib and whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer (NSCLC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Veliparib

Criteria

Inclusion Criteria:

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

• Subject must have brain metastases demonstrated on a magnetic resonance imaging (MRI) brain scan.

• Subject must be eligible for treatment with WBRT

• Subject must have had adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

• Subject is diagnosed with brain metastases greater than 28 days prior to Day 1

• 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 Day 1

• 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 metastases

• 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