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This study has been withdrawn prior to enrollment.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

Tracking Information

First Received Date ^ICMJE

June 10, 2010

Last Updated Date

February 6, 2012

Start Date ^ICMJE

November 2013

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01146171 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Japanese Phase 1 Study of BMS-844203 (CT322)

Official Title ^ICMJE

A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neoplasms

Intervention ^ICMJE

Drug: BMS-844203 (CT-322)

Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent

Study Arm (s)

Experimental: BMS-844203 (CT-322)

Intervention: Drug: BMS-844203 (CT-322)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01146171

Other Study ID Numbers ^ICMJE

CA196-007

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

February 2012

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

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