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

Sponsors and Collaborators:	Abbott Genentech
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00716534

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	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment
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

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Overall survival, time to tumor progression, objective response rate, best response rate, maximum percent reduction in tumor size and duration of response. [ Time Frame: Disease Progression ] [ Designated as safety issue: No ]
Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.20 mg/kg: Experimental	Drug: ABT-869 0.20 mg/kg

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.
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:

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) > 100 mm Hg or systolic BP > 150 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

Contacts

Contact: Brian L. Oliver, BS

847-938-5570

brian.oliver@abbott.com

Locations

United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Contact 404-727-6123
Principal Investigator: Suresh Ramalingam, MD
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact 800-789-7366
Principal Investigator: David Henry, MD

Sponsors and Collaborators

Abbott

Genentech

More Information

Responsible Party:	Abbott ( Joyce Steinberg MD/Global Medical Director )
Study ID Numbers:	M10-301
Study First Received:	July 14, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00716534
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009