Text Size

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This study has been withdrawn prior to enrollment.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
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013