A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer
Overview
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).
Full Title of Study: “A Phase 1b Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-833923 (XL139) in Combination With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2012
Interventions
- Drug: BMS-833923
- Capsule, Oral, starting dose 30 mg, once daily, continuous
- Drug: Carboplatin
- Vial, Intravenous (IV), dose to yield 5 mg/mL – min, once every 21 days, 1 day per cycle up to 4 cycles
- Drug: Etoposide
- Vial, Intravenous (IV), 100 mg/m²/dose, days 1, 2, & 3 of each 21 day cycle, 3 days per cycle for up to 4 cycles
Arms, Groups and Cohorts
- Experimental: All Subjects
Clinical Trial Outcome Measures
Primary Measures
- Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide
- Time Frame: 28 days
- NCI – National Cancer Institute CTCAE – Common Terminology Criteria for Adverse Events MTD – Maximum tolerated dose DLT – Dose limiting toxicity
Secondary Measures
- Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax)
- Time Frame: 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)
- Time Frame: 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)
- Time Frame: 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]
- Time Frame: 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
- Time Frame: At baseline and after 1 week
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Bristol-Myers Squibb
- Collaborator
- Exelixis
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.