A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
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| ClinicalTrials.gov Identifier: NCT00743938 |
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Recruitment Status :
Completed
First Posted : August 29, 2008
Last Update Posted : October 12, 2015
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| 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 |
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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+
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743938
Locations
| United States, Connecticut | |
| Yale University School Of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| Hematology Oncology, P.C. | |
| Stamford, Connecticut, United States, 06902-3628 | |
| United States, Massachusetts | |
| Mass General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202-2689 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Piedmont Hematology Oncology Associates, Pllc | |
| Winston-salem, North Carolina, United States, 27103 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Hema/Oncology Assoc. Of Nepa | |
| Dunmore, Pennsylvania, United States, 18512 | |
| United States, South Carolina | |
| Cancer Center Of The Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| Argentina | |
| Local Institution | |
| Bahia Blanca, Buenos Aires, Argentina | |
| Local Institution | |
| La Plata, Buenos Aires, Argentina, 1900 | |
| Local Institution | |
| Buenos Aires, Argentina | |
| Local Institution | |
| Cordoba, Argentina, X5000AAI | |
| Local Institution | |
| La Rioja, Argentina, 5300 | |
| Canada, Quebec | |
| Local Institution | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Local Institution | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| France | |
| Local Institution | |
| Lyon Cedex 08, France, 69373 | |
| Local Institution | |
| Marseille Cedex 20, France, 13915 | |
| Local Institution | |
| Strasbourg, France, 67000 | |
| Local Institution | |
| Toulouse, France, 31052 | |
| Local Institution | |
| Villejuif Cedex, France, 94800 | |
| Korea, Republic of | |
| Local Institution | |
| Gyeonggi-do, Korea, Republic of, 410-769 | |
| Local Institution | |
| Seoul, Korea, Republic of, 135-710 | |
| Local Institution | |
| Seoul, Korea, Republic of, 138-736 | |
| Poland | |
| Local Institution | |
| Otwock, Poland, 05-400 | |
| Spain | |
| Local Institution | |
| Barcelona, Spain, 08035 | |
| Local Institution | |
| Madrid, Spain, 28046 | |
| Local Institution | |
| Vizcaya, Spain, 48903 | |
| Taiwan | |
| Local Institution | |
| Taipei, Taiwan, 100 | |
| Local Institution | |
| Taipei, Taiwan, 112 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00743938 |
| Other Study ID Numbers: |
CA187-017 EUDRACT #: 2008-004691-44 |
| First Posted: | August 29, 2008 Key Record Dates |
| Last Update Posted: | October 12, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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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 |