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

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