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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) )

Tracking Information
First Submitted Date  ICMJE February 29, 2012
First Posted Date  ICMJE March 22, 2012
Last Update Posted Date October 21, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01560104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • 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.
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Small -Cell Lung Cancer
Intervention  ICMJE
  • Drug: Veliparib
    Other Name: ABT-888
  • Drug: Carboplatin
  • Drug: paclitaxel
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: veliparib and carboplatin and paclitaxel
    Veliparib on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle
    Interventions:
    • Drug: Veliparib
    • 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
    Interventions:
    • Drug: Carboplatin
    • Drug: paclitaxel
    • Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
160
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2012)
135
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Czech Republic,   France,   Germany,   Hungary,   Russian Federation,   Slovakia,   United States
 
Administrative Information
NCT Number  ICMJE NCT01560104
Other Study ID Numbers  ICMJE M10-898
2011-003427-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vincent Giranda, MD AbbVie
PRS Account AbbVie
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP