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

Sponsor:	Bristol-Myers Squibb
Collaborator:	Exelixis
Information provided by (Responsible Party):	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 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 ]
- NCI - National Cancer Institute
- CTCAE - Common Terminology Criteria for Adverse Events
- MTD - Maximum tolerated dose
- DLT - Dose limiting toxicity

Secondary Outcome Measures:

Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax) [ Time Frame: Day 1 and 15 of first three 21-day cycles ] [ Designated as safety issue: No ]
Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Time of maximum observed plasma concentration (Tmax) [ Time Frame: Day 1 and 15 of first three 21-day cycles ] [ Designated as safety issue: No ]
Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Area under the concentration-time curve in one dosing interval AUC(TAU) [ Time Frame: Day 1 and 15 of first three 21-day cycles ] [ Designated as safety issue: No ]
Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1] [ Time Frame: Every 6 weeks until disease progression ] [ Designated as safety issue: No ]
Pharmacodynamic effect (change from baseline) of BMS-833923 on Hedgehog pathway activation as measured by Glioma-associated oncogene -1 (GLI-1) expression [ Time Frame: At baseline and after 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	February 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: All Subjects	Drug: BMS-833923 Capsule, Oral, starting dose 30 mg, once daily, continuous Drug: Carboplatin Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles Other Name: Paraplatin® 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 Other Names: Etopophos® Toposar® VePesid®

Arms

Assigned Interventions

Experimental: All Subjects

Drug: BMS-833923

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

Drug: Carboplatin

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

Other Name: Paraplatin®

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

Other Names:

Etopophos®
Toposar®
VePesid®

Eligibility

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

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

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, Michigan
Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Shirish Gadgeel, Site 007
United States, North Carolina
University Of North Carolina At Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mark Socinski, Site 002
Australia, Victoria
Local Institution	Active, not recruiting
East Bentleigh, Victoria, Australia, 3165
Canada, Alberta
Local Institution	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 006
Canada, Ontario
Local Institution	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 005
France
Local Institution	Active, not recruiting
Villejuif Cedex, France, 94800
Ireland
Local Institution	Recruiting
Dublin, Ireland
Contact: Site 009

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

Investigator Inquiry form 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
ClinicalTrials.gov Identifier:	NCT00927875 History of Changes
Other Study ID Numbers:	CA194-005, 2010-018745-56
Study First Received:	June 9, 2009
Last Updated:	April 30, 2012
Health Authority:	United States: Food and Drug Administration France: Afssaps - French Health Products Safety Agency Ireland: Irish Medicines Board Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:

Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases

Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Etoposide
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2012