Status:
COMPLETED
A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Exelixis
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with carboplatin and etoposide followed by BMS-833923 alone in subjects with extens...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed small cell lung cancer, without prior chemotherapy treatment
- Men and Women at least 18 years old
- Eastern Cooperative Oncology Group (ECOG) status 0-2
Exclusion
- Significant cardiovascular disease
- Prior treatment of small cell lung cancer is not permitted, except for palliative radiation to a limited field excluding the chest (e.g. for painful metastasis).
- Symptomatic brain metastases
- Women pregnant or breastfeeding
- Women of childbearing potential (WOCBP) unwilling/unable to use acceptable method to avoid pregnancy
- Uncontrolled medical disorder or active infection
- Concurrent therapy with any other investigational product
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00927875
Start Date
February 1 2010
End Date
September 1 2012
Last Update
June 3 2013
Active Locations (6)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
Local Institution
East Bentleigh, Victoria, Australia, 3165
3
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
4
Local Institution
Ottawa, Ontario, Canada, K1H 8L6