Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00793897

Purpose

A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with paclitaxel and carboplatin for Phase 2 studies

Condition	Intervention	Phase
Advanced Solid Tumors Metastatic Solid Tumors	Drug: BMS-754807 Drug: Paclitaxel Drug: Carboplatin	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, Single Group Assignment, Safety Study
Official Title:	A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 [ Time Frame: Continuous assessment throughout the duration of the trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacodynamics: Biochemical parameters of drug action in serum [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: No ]
Metabolic measures: Effects of the drug on parameters of glucose homeostasis [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: Yes ]
Efficacy Measures: PET scans and tumor assessments by CT/MRI [ Time Frame: a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sequential allocation of patients in two dosing schedules: Experimental	Drug: BMS-754807 Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request Drug: Paclitaxel Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request Drug: Carboplatin Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Arms

Assigned Interventions

Sequential allocation of patients in two dosing schedules: Experimental

Drug: BMS-754807

Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request

Drug: Paclitaxel

Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Drug: Carboplatin

Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy
ECOG performance status 0-1
At least 4 weeks between surgery or last dose prior anti-cancer therapy

Exclusion Criteria:

Symptomatic brain metastases
Any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
Uncontrolled or significant cardiovascular disease
Inadequate bone marrow, liver or kidney function
Evidence of > Grade 1 peripheral neuropathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793897

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

Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8V 5C2
Korea, Republic of
Local Institution
Gyeonggi-Do, Korea, Republic of, 410-769
Local Institution
Seoul, Korea, Republic of, 138-736

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:	CA191-005
Study First Received:	November 17, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00793897
Health Authority:	Canada: Health Canada; Korea: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Subjects with Advanced or Metastatic Solid Tumors or Neoplasms

Study placed in the following topic categories:

Paclitaxel
Carboplatin

Additional relevant MeSH terms:

Neoplasms
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 15, 2009