A Clinical Study Conducted in Multiple Centers Comparing Veliparib in Combination With Carboplatin and Paclitaxel Versus a Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT01560104

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-09-30

Brief Summary

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).

Detailed Description

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.

Conditions

Non-Small -Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

veliparib and carboplatin and paclitaxel

Veliparib on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle

Group Type: EXPERIMENTAL

Veliparib

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

placebo and carboplatin and paclitaxel

Placebo on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle

Group Type: PLACEBO_COMPARATOR

Carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Interventions

Veliparib

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

ABT-888

Eligibility Criteria

Inclusion Criteria

• 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Giranda, MD

Role: STUDY_DIRECTOR

AbbVie

References

Ramalingam SS, Blais N, Mazieres J, Reck M, Jones CM, Juhasz E, Urban L, Orlov S, Barlesi F, Kio E, Keiholz U, Qin Q, Qian J, Nickner C, Dziubinski J, Xiong H, Ansell P, McKee M, Giranda V, Gorbunova V. Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2017 Apr 15;23(8):1937-1944. doi: 10.1158/1078-0432.CCR-15-3069. Epub 2016 Oct 10.

Reference Type: DERIVED

PMID: 27803064 (View on PubMed)

Other Identifiers

2011-003427-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-898

Identifier Type: -

Identifier Source: org_study_id