A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer
Phase 1
Completed
- Conditions
- Small Cell Lung Carcinoma
- Interventions
- Registration Number
- NCT00927875
- Lead Sponsor
- Bristol-Myers Squibb
- 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 extensive-stage Small Cell Lung Cancer (SCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Subjects BMS-833923 - All Subjects Carboplatin - All Subjects Etoposide -
- Primary Outcome Measures
Name Time Method Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide 28 days * NCI - National Cancer Institute
* CTCAE - Common Terminology Criteria for Adverse Events
* MTD - Maximum tolerated dose
* DLT - Dose limiting toxicity
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax) Day 1 and 15 of first three 21-day cycles Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Time of maximum observed plasma concentration (Tmax) Day 1 and 15 of first three 21-day cycles Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Area under the concentration-time curve in one dosing interval AUC(TAU) Day 1 and 15 of first three 21-day cycles Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1] Every 6 weeks until disease progression Pharmacodynamic effect (change from baseline) of BMS-833923 on Hedgehog pathway activation as measured by Glioma-associated oncogene -1 (GLI-1) expression At baseline and after 1 week
Trial Locations
- Locations (2)
Local Institution
🇮🇪Dublin, Ireland
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States