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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Non-Small -Cell Lung Cancer

Treatments: Drug: paclitaxel; Drug: placebo; Drug: Veliparib; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01560104

2011-003427-36 (EudraCT Number)

M10-898

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

veliparib and carboplatin and paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: paclitaxel

Drug: Veliparib

placebo and carboplatin and paclitaxel

Placebo Comparator group

Description:

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

Treatment:

Drug: Carboplatin

Drug: paclitaxel

Drug: placebo