Non-Small -Cell Lung Cancer Clinical Trial
Official title:
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)
A 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).
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Life expectancy > 12 weeks (as per Investigator's clinical
assessment). - Subject must have cytologically or histologically confirmed non-small cell lung cancer (NSCLC). - Subject must have metastatic or advanced non-small cell lung cancer (NSCLC) (stage IIIB or IV) that is not amenable to surgical resection or radiation with curative intent at time of study Screening. - Subject must have at least 1 unidimensional measurable non-small cell lung cancer (NSCLC) lesion on a Computed Tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). - Subject must consent to provide available archived formalin fixed, paraffin embedded (FFPE) tissue sample of non-small cell lung cancer (NSCLC) lesion (primary or metastatic) for central review and biomarker analysis. - Subject must have no history of brain metastases or evidence of primary central nervous system (CNS) tumors as demonstrated by a baseline magnetic resonance imaging (MRI). - Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. - Subjects with fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator. Exclusion Criteria: -Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). - Subject has a known hypersensitivity to platinum compounds. - Subjects with peripheral neuropathy = grade 2. - Subjects with a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21. (Subjects with wild type epidermal growth factor receptor (EGFR), unknown status or other type of epidermal growth factor receptor (EGFR) mutation will be considered eligible). - Subject has received prior systemic anti-cancer therapy for metastatic non-small cell lung cancer (NSCLC). - Subject has received adjuvant chemotherapy = 12 months prior to Cycle 1 Day 1. - Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day 1. - Subject has undergone External Beam Radiation Therapy (EBRT) = 8 weeks prior to Cycle 1 Day 1. - Clinically significant and uncontrolled major medical condition(s). - Subject has previously been treated with a poly-(ADP-ribose)-polymerase (PARP) inhibitor |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Overall Survival (OS) | Continuously from date of randomization until date of death from any cause or until patient is registered as off study, whichever came first. | Monthly after patient is registered off study up to 36 months or until date of death from any cause, whichever came first. | No |
| Secondary | Objective Response Rate (ORR) | 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 | |
| Secondary | Chemotherapy Induced Peripheral Neuropathy (CIPN) | From date of screening, first day of study treatment and then every cycle (about every 3 weeks) until date of death from any cause or patient is registered as off study, whichever came first. | No |