Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
Subjects will be randomized in a 2:1 ratio to one of the two treatment groups. The safety
of each treatment group will be assessed by evaluating study drug exposure, adverse events,
serious adverse events, all deaths, changes in laboratory determinations and vital sign
parameters. Progression -Free Survival (PFS) using Response Evaluation Criteria in Solid
Tumors (RECIST) (version 1.1) will be assessed as well as Overall Survival (OS) and the
Objective Response Rate (ORR). Study visits will be conducted according to the protocol
schedule. Study visits will include physical examination, laboratory blood sample
collection, and assessment of vital signs, medical history and urinalysis. 12-lead
Electrocardiogram (ECG) will be performed at protocol specified visits.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival (PFS)
Radiographic evaluation starting from the third day of study treatment and on average every 6 weeks until documented progression or date of death from any cause, whichever came first, until patient is registered as off study.
No
Vincent Giranda, MD
Study Director
AbbVie
United States: Food and Drug Administration
M10-898
NCT01560104
February 2012
October 2013
Name | Location |
---|---|
Site Reference ID/Investigator# 63712 | Atlanta, Georgia 30322 |
Site Reference ID/Investigator# 63979 | Boise, Idaho 83712 |
Site Reference ID/Investigator# 63978 | Peoria, Illinois 61615-7828 |
Site Reference ID/Investigator# 67403 | Zion, Illinois 60099 |
Site Reference ID/Investigator# 65691 | Goshen, Indiana 46526 |
Site Reference ID/Investigator# 67045 | New Albany, Indiana 47150 |
Site Reference ID/Investigator# 65507 | Hackensack, New Jersey 07601 |
Site Reference ID/Investigator# 63966 | Philadelphia, Pennsylvania 19111 |
Site Reference ID/Investigator# 67004 | Philadelphia, Pennsylvania 19106 |
Site Reference ID/Investigator# 63744 | Germantown, Tennessee 38138 |
Site Reference ID/Investigator# 68862 | Chandler, Arizona 85224 |
Site Reference ID/Investigator# 67008 | Detroit, Michigan 48201 |
Site Reference ID/Investigator# 65508 | Lansing, Michigan 48912 |