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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716534
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : April 29, 2013
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: A
12.5 mg ABT-869 + Carboplatin/Paclitaxel
Drug: ABT-869
12.5 mg 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)

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Disease Progression ]

Secondary Outcome Measures :
  1. 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 ]
  2. Survival Rate [ Time Frame: 12 Months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716534

  Hide Study Locations
United States, Arizona
Site Reference ID/Investigator# 15850
Chandler, Arizona, United States, 85224
Site Reference ID/Investigator# 15846
Peoria, Arizona, United States, 85381
United States, Florida
Site Reference ID/Investigator# 15841
Miami, Florida, United States, 33136
United States, Georgia
Site Reference ID/Investigator# 7179
Atlanta, Georgia, United States, 30322
United States, Michigan
Site Reference ID/Investigator# 15851
Lansing, Michigan, United States, 48912
United States, New Hampshire
Site Reference ID/Investigator# 15844
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Site Reference ID/Investigator# 22443
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Site Reference ID/Investigator# 15848
Greensboro, North Carolina, United States, 27403
United States, Ohio
Site Reference ID/Investigator# 22444
Canton, Ohio, United States, 44718
Site Reference ID/Investigator# 15847
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Site Reference ID/Investigator# 26842
Hershey, Pennsylvania, United States, 17033-0850
Site Reference ID/Investigator# 13101
Philadelphia, Pennsylvania, United States, 19106
Site Reference ID/Investigator# 24122
Philadelphia, Pennsylvania, United States, 19107
Site Reference ID/Investigator# 19042
Bedford Park, Australia, 5042
Site Reference ID/Investigator# 23682
Cairns, Australia, 4870
Site Reference ID/Investigator# 21862
Lismore, Australia, 2480
Site Reference ID/Investigator# 19043
Woodville South, Australia, 5011
Site Reference ID/Investigator# 17703
Jau, Brazil, 17210-120
Site Reference ID/Investigator# 23522
Porto Alegre, Brazil, 90050-170
Site Reference ID/Investigator# 15601
Porto Alegre, Brazil, 90610-000
Site Reference ID/Investigator# 17704
Rio de Janeiro, Brazil, 20231-050
Site Reference ID/Investigator# 22684
Santo Andre, Brazil, 09060-650
Site Reference ID/Investigator# 17702
Sao Paulo, Brazil, 01224-010
Site Reference ID/Investigator# 23582
Sao Paulo, Brazil, 04024-002
Czech Republic
Site Reference ID/Investigator# 18964
Kyjov, Czech Republic, 69733
Site Reference ID/Investigator# 22504
Nachod, Czech Republic, 54769
Site Reference ID/Investigator# 18963
Olomouc, Czech Republic, 77520
Site Reference ID/Investigator# 18962
Prague 2, Czech Republic, 12808
Site Reference ID/Investigator# 19022
Pribram V, Czech Republic, 26995
Russian Federation
Site Reference ID/Investigator# 38003
Kazan, Russian Federation, 420029
Site Reference ID/Investigator# 38260
Kirov, Russian Federation, 610021
Site Reference ID/Investigator# 18064
Moscow, Russian Federation, 115478
Site Reference ID/Investigator# 18065
Moscow, Russian Federation, 115478
Site Reference ID/Investigator# 23312
Moscow, Russian Federation, 115478
Site Reference ID/Investigator# 18066
Moscow, Russian Federation, 143423
Site Reference ID/Investigator# 23562
St. Petersburg, Russian Federation, 198255
Site Reference ID/Investigator# 18961
Singapore, Singapore, 119228
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Study Director: Justin L. Ricker, MD AbbVie

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00716534     History of Changes
Other Study ID Numbers: M10-301
2007-007107-32 ( EudraCT Number )
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

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