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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Small Cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All Subjects

Group Type EXPERIMENTAL

BMS-833923

Intervention Type DRUG

Capsule, Oral, starting dose 30 mg, once daily, continuous

Carboplatin

Intervention Type DRUG

Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles

Etoposide

Intervention Type DRUG

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

Interventions

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BMS-833923

Capsule, Oral, starting dose 30 mg, once daily, continuous

Intervention Type DRUG

Carboplatin

Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Paraplatin® Etopophos® Toposar® VePesid®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No