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

Advanced or Metastatic Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716534
• Other study ID #: M10-301
• Secondary ID: 2007-007107-32
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2008
• Last updated: April 19, 2013
• Start date: June 2008
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCzech Republic: Ethics CommitteeRussia: Ministry of Health of the Russian FederationBrazil: National Health Surveillance AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Ministry of HealthSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced or Metastatic Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• ABT-869
12.5 mg ABT-869
• Placebo for ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)
• ABT-869
7.5 mg ABT-869
• Carboplatin
Carboplatin (AUC 6 mg/mL/min)
• Paclitaxel
Paclitaxel (200 mg/m2)

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 19042	Bedford Park
Australia	Site Reference ID/Investigator# 23682	Cairns
Australia	Site Reference ID/Investigator# 21862	Lismore
Australia	Site Reference ID/Investigator# 19043	Woodville South
Brazil	Site Reference ID/Investigator# 17703	Jau
Brazil	Site Reference ID/Investigator# 15601	Porto Alegre
Brazil	Site Reference ID/Investigator# 23522	Porto Alegre
Brazil	Site Reference ID/Investigator# 17704	Rio de Janeiro
Brazil	Site Reference ID/Investigator# 22684	Santo Andre
Brazil	Site Reference ID/Investigator# 17702	Sao Paulo
Brazil	Site Reference ID/Investigator# 23582	Sao Paulo
Czech Republic	Site Reference ID/Investigator# 18964	Kyjov
Czech Republic	Site Reference ID/Investigator# 22504	Nachod
Czech Republic	Site Reference ID/Investigator# 18963	Olomouc
Czech Republic	Site Reference ID/Investigator# 18962	Prague 2
Czech Republic	Site Reference ID/Investigator# 19022	Pribram V
Russian Federation	Site Reference ID/Investigator# 38003	Kazan
Russian Federation	Site Reference ID/Investigator# 38260	Kirov
Russian Federation	Site Reference ID/Investigator# 18064	Moscow
Russian Federation	Site Reference ID/Investigator# 18065	Moscow
Russian Federation	Site Reference ID/Investigator# 18066	Moscow
Russian Federation	Site Reference ID/Investigator# 23312	Moscow
Russian Federation	Site Reference ID/Investigator# 23562	St. Petersburg
Singapore	Site Reference ID/Investigator# 18961	Singapore
United States	Site Reference ID/Investigator# 7179	Atlanta	Georgia
United States	Site Reference ID/Investigator# 22444	Canton	Ohio
United States	Site Reference ID/Investigator# 15850	Chandler	Arizona
United States	Site Reference ID/Investigator# 15847	Cleveland	Ohio
United States	Site Reference ID/Investigator# 15848	Greensboro	North Carolina
United States	Site Reference ID/Investigator# 22443	Hackensack	New Jersey
United States	Site Reference ID/Investigator# 26842	Hershey	Pennsylvania
United States	Site Reference ID/Investigator# 15851	Lansing	Michigan
United States	Site Reference ID/Investigator# 15844	Lebanon	New Hampshire
United States	Site Reference ID/Investigator# 15841	Miami	Florida
United States	Site Reference ID/Investigator# 15846	Peoria	Arizona
United States	Site Reference ID/Investigator# 13101	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 24122	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Czech Republic,  Russian Federation,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		Disease Progression	No
Secondary	Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response		Disease Progression	No
Secondary	Survival Rate		12 Months	No