Japanese Phase 1 Study of BMS-844203 (CT322)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01146171
First received: June 10, 2010
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Neoplasms
Drug: BMS-844203 (CT-322)
Phase 1

Study Type: Interventional
Study Design: 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-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Determine recommended dose for Phase 2 study of CT-322 [ Time Frame: Within the first 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess anti-tumor activity of CT-322 [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of CT-322 on plasma VEGF levels [ Time Frame: Cycle 1: Day 1, 3, 8, 15, 22 ] [ Designated as safety issue: No ]
  • To assess the effects of CT-322 on plasma VEGF levels [ Time Frame: Cycle 3: Day 1 ] [ Designated as safety issue: No ]
  • To assess the presence of anti CT-322 antibodies [ Time Frame: Cycle 1: Day 1, 15, 22 and 29 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: November 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-844203 (CT-322) Drug: BMS-844203 (CT-322)
Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01146171

Locations
Japan
Local Institution
Osaka-Sayama-Shi, Osaka, Japan, 5898511
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01146171     History of Changes
Other Study ID Numbers: CA196-007
Study First Received: June 10, 2010
Last Updated: February 6, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on September 18, 2014