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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569036
First Posted: December 6, 2007
Last Update Posted: August 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Intervention Model: Single Group Assignment
Masking: None (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

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 ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: assessed during the first 4 weeks of the study ]
  • Pharmacodynamics [ Time Frame: assessed during the first 4 weeks of the study ]
  • Metabolic measures [ Time Frame: assessed during the first 4 weeks of the study ]
  • ECG [ Time Frame: assessed during the first 4 weeks of the study ]
  • Efficacy Measures [ Time Frame: assessed every 8 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00569036     History of Changes
Other Study ID Numbers: CA191-002
First Submitted: December 4, 2007
First Posted: December 6, 2007
Last Update Posted: August 14, 2013
Last Verified: August 2013

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