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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Drug: BMS-690514; Drug: Erlotinib	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	141 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
Study Start Date :	March 2009
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	June 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A1	Drug: BMS-690514; Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity; Other Name: panHER
Active Comparator: B2	Drug: Erlotinib; Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity; Other Name: Tarceva

Outcome Measures

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Primary Outcome Measures :

1. To compare the progression-free survival of patients on BMS-690514 with those on erlotinib [ Time Frame: CT/MRI at baseline and every 6 weeks for 36 weeks ]

Secondary Outcome Measures :

1. To compare the overall survival between BMS-690514 and erlotinib [ Time Frame: 15 months ]
2. To estimate the overall response rate of BMS-690514 or erlotinib [ Time Frame: 15 months ]
3. To estimate the tumor size change and PFS rate at 6 weeks [ Time Frame: 6 weeks ]
4. To assess safety and tolerability of BMS-690514 and erlotinib [ Time Frame: 15 months ]
5. To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib [ Time Frame: 15 months ]
6. To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients [ Time Frame: Days 1,8,15, 29 ]

Eligibility Criteria

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

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+

Contacts and Locations

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  Show 30 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trial Information 

BMS clinical trial educational resource 

Investigator Inquiry form 

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00743938 History of Changes
Other Study ID Numbers:	CA187-017; EUDRACT #: 2008-004691-44
First Posted:	August 29, 2008
Last Update Posted:	October 12, 2015
Last Verified:	September 2015

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms	Lung Diseases; Respiratory Tract Diseases; Erlotinib Hydrochloride; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action