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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Small Cell Lung Carcinoma

Treatments: Drug: Carboplatin; Drug: Etoposide; Drug: BMS-833923

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927875

2010-018745-56 (EudraCT Number)

CA194-005

Details and patient eligibility

About

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).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

All Subjects

Experimental group

Treatment:

Drug: Etoposide

Drug: BMS-833923

Drug: Carboplatin