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Randomized, Double-Blind, Multicenter, Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02106546
First received: April 4, 2014
Last updated: July 7, 2016
Last verified: July 2016
  Purpose
This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in subjects with advanced or metastatic squamous NSCLC.

Condition Intervention Phase
Squamous Non-Small Cell Lung Cancer
Drug: veliparib
Drug: carboplatin
Drug: paclitaxel
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Overall Survival (OS) in current smokers [ Time Frame: Up to 3 years from first dose of study drug ] [ Designated as safety issue: No ]
    Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.


Secondary Outcome Measures:
  • Overall Survival (OS) in all subjects [ Time Frame: Up to 3 years from first dose of study drug ] [ Designated as safety issue: No ]
    Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.

  • Progressive-Free Survival (PFS) in current smokers and in all subjects [ Time Frame: Up to 3 years from first dose of study drug ] [ Designated as safety issue: No ]
    Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.

  • Objective Response Rate (ORR) in current smokers and in all subjects [ Time Frame: Up to 3 years from first dose of study drug ] [ Designated as safety issue: No ]
    Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1)


Other Outcome Measures:
  • Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: From Screening (prior to dosing) up to 2 years ] [ Designated as safety issue: No ]
  • Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) [ Time Frame: From Screening (prior to dosing) up to 2 years ] [ Designated as safety issue: No ]
  • Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30). [ Time Frame: From Screening (prior to dosing) up to 2 years ] [ Designated as safety issue: No ]
  • Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13). [ Time Frame: From Screening (prior to dosing) up to 2 years ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: From complete or partial response to disease progression (up to 3 years from randomization). ] [ Designated as safety issue: No ]
    The duration of overall response for a given subject will be defined as the number of days from the day the criteria are met for Complete or Partial Response (whichever is recorded first) to the date that Progressive Disease (PD) is objectively documented.


Estimated Enrollment: 975
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: veliparib and carboplatin and paclitaxel
veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
Drug: veliparib
Oral Capsule
Other Name: ABT-888
Drug: carboplatin
Intravenous infusion
Drug: paclitaxel
Intravenous infusion
Placebo Comparator: placebo and carboplatin and paclitaxel
placebo on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
Drug: carboplatin
Intravenous infusion
Drug: paclitaxel
Intravenous infusion
Drug: placebo
Oral Capsule

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Life expectancy > 12 weeks
  2. Subject must have cytologically or histologically confirmed squamous NSCLC.
  3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
  4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
  5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a Computerized Tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1).

Exclusion Criteria:

  1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
  2. Subject has a known hypersensitivity to platinum compounds.
  3. Subject has peripheral neuropathy >= grade 2.
  4. Subject has non-squamous NSCLC, or a known Epidermal Growth Factor Receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known Anaplastic Lymphoma Kinase (ALK) gene rearrangement.
  5. Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
  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: NCT02106546

  Show 228 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Mark D McKee, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02106546     History of Changes
Other Study ID Numbers: M11-089  2013-005020-42 
Study First Received: April 4, 2014
Last Updated: July 7, 2016
Health Authority: Italy: Ethics Committee
Canada: Institutional Review Board
South Africa: Medicines Control Council
Canada: Ethics Review Committee
Germany: Ethics Commission
Mexico: Ethics Committee
Turkey: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Egypt: Ministry of Health and Population
Latvia: State Agency of Medicines
Canada: Health Canada
Greece: National Organization of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
Italy: The Italian Medicines Agency
Lithuania: Bioethics Committee
Switzerland: Swissmedic
South Africa: Human Research Ethics Committee
Slovakia: State Institute for Drug Control
Serbia: Medicines and Medical Devices Agency
Spain: Comité Ético de Investigación Clínica
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Conseil National de l'Ordre des Médecins
Czech Republic: State Institute for Drug Control
Ireland: Irish Medicines Board
Norway: Norwegian Medicines Agency
Portugal: Data Protection Agency
Russia: Ethics Committee
Belarus: Ministry of Health
Denmark: Danish Health and Medicines Authority
Sweden: Institutional Review Board
Australia: Human Research Ethics Committee
Brazil: National Committee of Ethics in Research
Hungary: Research Ethics Medical Committee
Switzerland: Ethikkommission
Mexico: Ministry of Health
Greece: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
New Zealand: Health and Disability Ethics Committees
United States: Food and Drug Administration
Austria: Austrian Medicines and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: Ethics Committee
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Brazil: Ministry of Health
Portugal: Ethics Committee for Clinical Research
Finland: Ethics Committee
France: National Consultative Ethics Committee for Health and Life Sciences
Latvia: Institutional Review Board
Ireland: Research Ethics Committee
Sweden: Medical Products Agency
Russia: Ministry of Health of the Russian Federation
Israel: Ethics Commission
Poland: Ethics Committee
Netherlands: Ministry of Health, Welfare and Sport
Serbia: Ethics Committee
France: The Commission nationale de l’informatique et des libertés
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Finland: Finnish Medicines Agency
Norway: Ethics Committee
New Zealand: Medsafe
Turkey: Ethics Committee
Croatia: Agency for Medicinal Product and Medical Devices
United Kingdom: Research Ethics Committee
Austria: Ethikkommission

Keywords provided by AbbVie:
carboplatin
Randomized
veliparib
Advanced
Metastatic
Overall Survival
Squamous
placebo controlled
ABT-888
Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)
non-small cell lung cancer
paclitaxel

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
Paclitaxel
Veliparib
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016