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: September 23, 2015
Last verified: September 2015
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
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 ]
Secondary Outcome Measures:
- To compare the overall survival between BMS-690514 and erlotinib [ Time Frame: 15 months ]
- To estimate the overall response rate of BMS-690514 or erlotinib [ Time Frame: 15 months ]
- To estimate the tumor size change and PFS rate at 6 weeks [ Time Frame: 6 weeks ]
- To assess safety and tolerability of BMS-690514 and erlotinib [ Time Frame: 15 months ]
- To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib [ Time Frame: 15 months ]
- To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients [ Time Frame: Days 1,8,15, 29 ]
| 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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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:
| 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: | September 23, 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 |
ClinicalTrials.gov processed this record on May 23, 2017