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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Carcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide

Outcome Description:

NCI - National Cancer Institute CTCAE - Common Terminology Criteria for Adverse Events MTD - Maximum tolerated dose DLT - Dose limiting toxicity

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA194-005

NCT ID:

NCT00927875

Start Date:

February 2010

Completion Date:

September 2012

Related Keywords:

  • Small Cell Lung Carcinoma
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
Karmanos Cancer Institute Detroit, Michigan  48201