Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
1 other identifier
interventional
63
1 country
5
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2008
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2007
CompletedFirst Posted
Study publicly available on registry
December 6, 2007
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedAugust 14, 2013
August 1, 2013
5 years
December 4, 2007
August 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Continuous assessment throughout the duration of the trial
Secondary Outcomes (5)
Pharmacokinetics
assessed during the first 4 weeks of the study
Pharmacodynamics
assessed during the first 4 weeks of the study
Metabolic measures
assessed during the first 4 weeks of the study
ECG
assessed during the first 4 weeks of the study
Efficacy Measures
assessed every 8 weeks
Study Arms (1)
BMS-754807
EXPERIMENTALSingle arm, multiple-ascending dose escalation study
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Local Institution
East Melbourne, Victoria, 3002, Australia
Local Institution
Footscray, Victoria, 3011, Australia
Local Institution
Heidelberg, Victoria, 3084, Australia
Local Institution
Parkville, Victoria, 3050, Australia
Local Institution
Nedlands, Western Australia, 6009, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2007
First Posted
December 6, 2007
Study Start
April 1, 2008
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 14, 2013
Record last verified: 2013-08