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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01560104
First received: February 29, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Non-Small -Cell Lung Cancer
Drug: Veliparib
Drug: Carboplatin
Drug: paclitaxel
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
see arm description
Other Name: ABT-888
Drug: Carboplatin
see arm description
Drug: paclitaxel
see arm description
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
see arm description
Drug: paclitaxel
see arm description
Drug: placebo
see arm description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560104

  Show 40 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Vincent Giranda, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01560104     History of Changes
Other Study ID Numbers: M10-898, 2011-003427-36
Study First Received: February 29, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence francaise de securite sanitaire des produits de sante (Saint-Denis)
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Slovenia: Ministry of Health
Slovakia: State Institute for Drug Control
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation

Keywords provided by AbbVie:
carboplatin
non-small cell lung cancer
paclitaxel
metastatic
Randomized
veliparib
ABT-888
progression free survival
PARP

Additional relevant MeSH terms:
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
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014