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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00793897

First received: November 17, 2008

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2008

Last Updated Date

July 12, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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: starting with dosing on Day 1 until after 30 day follow-up following the last dose ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00793897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
Pharmacokinetic Measures: Blood samples will be collected during pre-specified times [ Time Frame: Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Solid Tumors
Metastatic Solid Tumors

Intervention ^ICMJE

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

Other Name: IGF-IR
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
Other Names:
- Taxol
- BMS-181339
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
Other Names:
- Paraplatin
- BMY-26575

Study Arm (s)

Experimental: Sequential allocation of patients in two dosing schedules

Interventions:

Drug: BMS-754807
Drug: Paclitaxel
Drug: Carboplatin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Canada, Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00793897

Other Study ID Numbers ^ICMJE

CA191-005

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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