Clinical trial NCT00743938: A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
Official title: A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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+

Primary outcomes:
measure: To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
timeFrame: CT/MRI at baseline and every 6 weeks for 36 weeks
Secondary outcomes:
measure: To compare the overall survival between BMS-690514 and erlotinib
timeFrame: 15 months
measure: To estimate the overall response rate of BMS-690514 or erlotinib
timeFrame: 15 months
measure: To estimate the tumor size change and PFS rate at 6 weeks
timeFrame: 6 weeks
measure: To assess safety and tolerability of BMS-690514 and erlotinib
timeFrame: 15 months
measure: To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib
timeFrame: 15 months
measure: To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients
timeFrame: Days 1,8,15, 29
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Stamford
country: United States
facility: Hematology Oncology, P.C.
state: Connecticut
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Winston-salem
country: United States
facility: Piedmont Hematology Oncology Associates, Pllc
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dunmore
country: United States
facility: Hema/Oncology Assoc. Of Nepa
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Center Of The Carolinas
state: South Carolina
city: Bahia Blanca
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: La Rioja
country: Argentina
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution
state: Quebec
city: Lyon Cedex 08
country: France
facility: Local Institution
city: Marseille Cedex 20
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Otwock
country: Poland
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Vizcaya
country: Spain
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: