A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00420186

Purpose

The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin

Condition	Intervention	Phase
Cancer (Solid Tumors)	Drug: BMS-690514	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Describe anti-tumor activity [ Time Frame: upon occurence ] [ Designated as safety issue: No ]
Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research [ Time Frame: upon occurence ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: BMS-690514 Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos

Eligibility

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

Criteria

Inclusion Criteria:

Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
Centrally located squamous cell carcinoma of the lung is permitted
ECOG performance status of 0-1
Life expectancy of at least 3 months
Men and women age 18 and above

Exclusion Criteria:

Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
Peripheral neuropathy ≥Grade 1 for any reason
History of thromboembolic disease or bleeding diatheses within the last 6 months
Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
Serious, uncontrolled medical disorder or active infection
Uncontrolled or significant cardiac disease
Uncontrolled hypertension (150/100)
Allergy to Cremophor EL®

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420186

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, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263
Contact: Grace Dy, Site 001 716-845-4101
United States, Pennsylvania
Local Institution	Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site 006
Canada, Ontario
Local Institution	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 005

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA187-004
Study First Received:	January 8, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00420186
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Paclitaxel
Carboplatin

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009