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Japanese Phase 1 Study of BMS-844203 (CT322)

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.
ClinicalTrials.gov Identifier: NCT01146171
Recruitment Status : Withdrawn
First Posted : June 17, 2010
Last Update Posted : February 7, 2012
Sponsor:
Information provided by:

June 10, 2010
June 17, 2010
February 7, 2012
November 2013
January 2015   (Final data collection date for primary outcome measure)
Determine recommended dose for Phase 2 study of CT-322 [ Time Frame: Within the first 28 days ]
Same as current
Complete list of historical versions of study NCT01146171 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: Every 8 weeks ]
  • To assess the effects of CT-322 on plasma VEGF levels [ Time Frame: Cycle 1: Day 1, 3, 8, 15, 22 ]
  • To assess the effects of CT-322 on plasma VEGF levels [ Time Frame: Cycle 3: Day 1 ]
  • To assess the presence of anti CT-322 antibodies [ Time Frame: Cycle 1: Day 1, 15, 22 and 29 ]
  • To assess the presence of anti CT-322 antibodies [ Time Frame: Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter ]
Same as current
Not Provided
Not Provided
 
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
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
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: BMS-844203 (CT-322)
Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent
Experimental: BMS-844203 (CT-322)
Intervention: Drug: BMS-844203 (CT-322)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subject has uncontrolled diabetes or hypertension
  • Clinical significant bleeding diathesis or coagulopathy
  • Thrombotic or embolic cerebrovascular accident
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01146171
CA196-007
No
Not Provided
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP