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

This study is not yet open for participant recruitment.

Verified by Bristol-Myers Squibb, July 2009

First Received: June 9, 2009 Last Updated: September 2, 2009 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb Exelixis
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00927875

Purpose

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).

Condition	Intervention	Phase
Small Cell Lung Carcinoma	Drug: BMS-833923 Drug: Carboplatin Drug: Etoposide	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Etoposide Carboplatin Etoposide phosphate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate Pharmacokinetics of BMS-833923 alone and in combination with carboplatin and etoposide [ Time Frame: At a minimum on days 1, 8, 15 and 35 of monotherapy, combination therapy and maintenance therapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
All Subjects: Experimental	Drug: BMS-833923 Capsule, Oral, starting dose 30 mg, once daily, continuous Drug: Carboplatin Vial, IV, dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles Drug: Etoposide Vial, IV, 100 mg/m²/dose, days 1, 2, & 3 of each 21 day cycle, 3 days per cycle for up to 4 cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed small cell lung cancer, without prior chemotherapy treatment
Men and Women at least 18 years old
ECOG status 0-1

Exclusion Criteria:

Significant cardiovascular disease
Previous treatment
Known brain metastases
Women pregnant or breastfeeding
WOCBP unwilling/unable to use acceptable method to avoid pregnancy
Uncontrolled medical disorder or active infection
Concurrent therapy with any other investigational product

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927875

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Illinois
Local Institution
Chicago, Illinois, United States, 60612
United States, North Carolina
Local Institution
Chapel Hill, North Carolina, United States, 27599
Australia, Victoria
Local Institution
East Bentleigh, Victoria, Australia, 3165

Sponsors and Collaborators

Bristol-Myers Squibb

Exelixis

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA194-005
Study First Received:	June 9, 2009
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00927875 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carboplatin
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Carboplatin
Etoposide phosphate
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 09, 2009