Trial record 3 of 6 for:    veliparib ABT-888 NSCLC

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 currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02106546
First received: April 4, 2014
Last updated: July 28, 2014
Last verified: July 2014
  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) [ 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:
  • Progression-Free Survival (PFS) [ 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) [ 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 Response Evaluation Criteria In Solid Tumors (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: 900
Study Start Date: April 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: March 2016 (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 and older
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 for advanced or metastatic NSCLC.
  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

Contacts
Contact: Angela M Deluca, BA +1 847-936-3354 angela.deluca@abbvie.com
Contact: Courtney A Caskey, BS +1 847-938-6427 courtney.caskey@abbvie.com

  Show 104 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Mark D McKee, MD AbbVie
  More Information

No publications provided

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 28, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belarus: Ministry of Health
Canada: Health Canada
Finland: Finnish Medicines Agency
Lithuania: Bioethics Committee
Russia: Ministry of Health of the Russian Federation
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Lithuania: State Medicine Control Agency - Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency
Germany: Ethics Commission
Sweden: Medical Products Agency
Turkey: Ethics Committee
Norway: Norwegian Medicines Agency
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
United Kingdom: Research Ethics Committee
Portugal: Data Protection Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Portugal: Ethics Committee for Clinical Research
France: National Consultative Ethics Committee for Health and Life Sciences
Spain: Comité Ético de Investigación Clínica
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés
Ireland: Research Ethics Committee
Ireland: Irish Medicines Board
Slovakia: State Institute for Drug Control
Austria: Ethikkommission

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014