A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00743938
First received: August 27, 2008
Last updated: May 31, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: BMS-690514 Drug: Erlotinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the overall survival between BMS-690514 and erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- To estimate the overall response rate of BMS-690514 or erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- To estimate the tumor size change and PFS rate at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- To assess safety and tolerability of BMS-690514 and erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
- To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients [ Time Frame: Days 1,8,15, 29 ] [ Designated as safety issue: No ]
| Enrollment: | 141 |
| Study Start Date: | March 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00743938
Show 30 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743938
Show 30 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00743938 History of Changes |
| Other Study ID Numbers: | CA187-017, EUDRACT #: 2008-004691-44 |
| Study First Received: | August 27, 2008 |
| Last Updated: | May 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases |
Respiratory Tract Neoplasms Thoracic Neoplasms Erlotinib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015