NCT01657799

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Brain Metastases From Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Veliparib	Veliparib capsules for oral administration
DRUG	Placebo	Placebo to veliparib capsules for oral administration
RADIATION	Whole brain radiation therapy	30.0 grays (Gy) of WBRT given in 10 daily fractions of 3.0 Gy each, excluding weekends and holidays

Timeline

• Start date: 2012-10-19
• Primary completion: 2015-01-22
• Completion: 2015-01-22
• First posted: 2012-08-06
• Last updated: 2018-06-06
• Results posted: 2018-02-14