Overview

A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Collaborator:
Exelixis
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
Criteria
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