Japanese Phase 1 Study of BMS-844203 (CT322)
A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 7, 2012
February 1, 2012
1.2 years
June 10, 2010
February 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Determine recommended dose for Phase 2 study of CT-322
Within the first 28 days
Secondary Outcomes (7)
To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
Cycle 1: Day 1 to 5, 8, 15, 22 to 26 and 29
To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
To assess anti-tumor activity of CT-322
Every 8 weeks
To assess the effects of CT-322 on plasma VEGF levels
Cycle 1: Day 1, 3, 8, 15, 22
To assess the effects of CT-322 on plasma VEGF levels
Cycle 3: Day 1
- +2 more secondary outcomes
Study Arms (1)
BMS-844203 (CT-322)
EXPERIMENTALInterventions
Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent
Eligibility Criteria
You may qualify if:
- Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance 0-1
You may not qualify if:
- Subject has uncontrolled diabetes or hypertension
- Clinical significant bleeding diathesis or coagulopathy
- Thrombotic or embolic cerebrovascular accident
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Osaka-Sayama-Shi, Osaka, 5898511, Japan
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 17, 2010
Study Start
November 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
February 7, 2012
Record last verified: 2012-02