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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

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ClinicalTrials.gov Identifier: NCT01560104
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Non-Small -Cell Lung Cancer Drug: Veliparib Drug: Carboplatin Drug: paclitaxel Drug: placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : February 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: veliparib and carboplatin and paclitaxel
Veliparib on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle
 Drug: Veliparib
Other Name: ABT-888

Drug: Carboplatin
Drug: paclitaxel
Placebo Comparator: placebo and carboplatin and paclitaxel
Placebo on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle
 Drug: Carboplatin
Drug: paclitaxel
Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 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. ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Monthly after patient is registered off study up to 36 months or until date of death from any cause, whichever came first. ]
    Continuously from date of randomization until date of death from any cause or until patient is registered as off study, whichever came first.

  2. Objective Response Rate (ORR) [ Time Frame: 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. ]
  3. Chemotherapy Induced Peripheral Neuropathy (CIPN) [ Time Frame: 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560104


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Vincent Giranda, MD AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01560104    
Other Study ID Numbers: M10-898
2011-003427-36 ( EudraCT Number )
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: September 2015
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Randomized
metastatic
ABT-888
paclitaxel
non-small cell lung cancer
 PARP
veliparib
progression free survival
carboplatin
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
 Carboplatin
Veliparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors