A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743938
• Other study ID #: CA187-017
• Secondary ID: EUDRACT #: 2008-
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: September 23, 2015
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ECOG PS of 0 or 1

• Histologically confirmed NSCLC

• Adequate amount of tumor (archived or fresh) for biomarker evaluation

• Received one to two regimens of chemotherapy (with at least one platinum-containing)

• Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min

• Stable control of blood pressure on agents other than calcium channel blockers

• Women of child-bearing potential must avoid pregnancy or maintain adequate contraception

• Must be able to swallow pills and take the medications at the same time every day on an empty stomach

Exclusion Criteria:

• ECOG PS 2 or greater

• Women unwilling to avoid pregnancy or use adequate contraception

• Symptomatic brain metastases

• Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)

• History of hemoptysis greater than 10 mL/day

• Significant cardiovascular disease

• Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease

• History of use of other TKIs

• Uncontrolled hypertension

• HIV+

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• BMS-690514
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
• Erlotinib
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity

Locations

Country	Name	City	State
Argentina	Local Institution	Bahia Blanca	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	La Plata	Buenos Aires
Argentina	Local Institution	La Rioja
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Sherbrooke	Quebec
France	Local Institution	Lyon Cedex 08
France	Local Institution	Marseille Cedex 20
France	Local Institution	Strasbourg
France	Local Institution	Toulouse
France	Local Institution	Villejuif Cedex
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Poland	Local Institution	Otwock
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Vizcaya
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
United States	Mass General Hospital	Boston	Massachusetts
United States	Henry Ford Hospital	Detroit	Michigan
United States	Hema/Oncology Assoc. Of Nepa	Dunmore	Pennsylvania
United States	Cancer Center Of The Carolinas	Greenville	South Carolina
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Hematology Oncology, P.C.	Stamford	Connecticut
United States	Piedmont Hematology Oncology Associates, Pllc	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  France,  Korea, Republic of,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the progression-free survival of patients on BMS-690514 with those on erlotinib		CT/MRI at baseline and every 6 weeks for 36 weeks	No
Secondary	To compare the overall survival between BMS-690514 and erlotinib		15 months	No
Secondary	To estimate the overall response rate of BMS-690514 or erlotinib		15 months	No
Secondary	To estimate the tumor size change and PFS rate at 6 weeks		6 weeks	No
Secondary	To assess safety and tolerability of BMS-690514 and erlotinib		15 months	Yes
Secondary	To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib		15 months	No
Secondary	To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients		Days 1,8,15, 29	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form