Text Size

Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00716534
First received: July 14, 2008
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.


Condition Intervention Phase
Advanced or Metastatic Non-Small Cell Lung Cancer
 Drug: ABT-869
Drug: Placebo for ABT-869
Drug: Carboplatin
Drug: Paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Disease Progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response [ Time Frame: Disease Progression ] [ Designated as safety issue: No ]
  • Survival Rate [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
12.5 mg ABT-869 + Carboplatin/Paclitaxel
 Drug: ABT-869
12.5 mg ABT-869
Other Name: ABT-869
Drug: Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Drug: Paclitaxel
Paclitaxel (200 mg/m2)
Experimental: B
7.5 mg ABT-869 + Carboplatin/Paclitaxel
 Drug: ABT-869
7.5 mg ABT-869
Drug: Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Drug: Paclitaxel
Paclitaxel (200 mg/m2)
Placebo Comparator: C
Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
 Drug: Placebo for ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)
Other Name: Placebo
Drug: Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Drug: Paclitaxel
Paclitaxel (200 mg/m2)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject must have cytologically or histologically confirmed non-squamous NSCLC
  • Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
  • Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
  • Subject has an ECOG Performance Score of 0-1.
  • Willing to take adequate measures to prevent pregnancy.

Exclusion Criteria:

  • The subject has NSCLC with a predominant squamous cell histology
  • Subject has hypersensitivity to paclitaxel.
  • Subject has received any anti-cancer therapy for treatment of NSCLC.
  • Subject has received radiation therapy within 21 days of Study Day 1.
  • Subject has had major surgery within 21 days.
  • Subject has untreated brain or meningeal metastases.
  • Subject is receiving therapeutic anticoagulation therapy.
  • Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
  • Subject has proteinuria CTC Grade > 1 at baseline.
  • Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
  • The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.
  • The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
  • The subject has a documented left ventricular (LV) ejection fraction < 50%.
  • The subject has known autoimmune disease with renal involvement (i.e., lupus).
  • The subject is receiving combination anti-retroviral therapy for HIV.
  • The subject has clinically significant uncontrolled condition(s).
  • The subject has a history of another active cancer within the past 5 years.
  • The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
  • The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
  • The subject is pregnant or breast feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716534

  Show 37 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech
Investigators
Study Director: Justin L. Ricker, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00716534     History of Changes
Other Study ID Numbers: M10-301, 2007-007107-32
Study First Received: July 14, 2008
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration
Czech Republic: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Brazil: National Health Surveillance Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Ministry of Health
Singapore: Health Sciences Authority

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 May 22, 2013