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Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00569036
First received: December 4, 2007
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 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 for Phase 2 studies


Condition Intervention Phase
Neoplasms
Solid Tumors
Metastases
 Drug: BMS-754807
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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:
  • Pharmacokinetics [ Time Frame: assessed during the first 4 weeks of the study ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: assessed during the first 4 weeks of the study ] [ Designated as safety issue: No ]
  • Metabolic measures [ Time Frame: assessed during the first 4 weeks of the study ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: assessed during the first 4 weeks of the study ] [ Designated as safety issue: Yes ]
  • Efficacy Measures [ Time Frame: assessed every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: April 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-754807
Single arm, multiple-ascending dose escalation study
 Drug: BMS-754807
Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request
Other Name: IGF-IR

  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 the standard of care is ineffective or inappropriate
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569036

Locations
Australia, Victoria
Local Institution
East Melbourne, Victoria, Australia, 3002
Local Institution
Footscray, Victoria, Australia, 3011
Local Institution
Heidelberg, Victoria, Australia, 3084
Local Institution
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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: NCT00569036     History of Changes
Other Study ID Numbers: CA191-002
Study First Received: December 4, 2007
Last Updated: July 3, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bristol-Myers Squibb:
Advanced or Metastatic Solid Tumors or Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013