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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00569036
First received: December 4, 2007
Last updated: August 13, 2013
Last verified: August 2013
  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:


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 ]

Enrollment: 63
Study Start Date: April 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: August 13, 2013
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 August 01, 2014