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

Study Overview

• Status: Withdrawn
• Conditions: Neoplasms
• Intervention / Treatment: Drug: BMS-844203 (CT-322)

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Osaka-Sayama-Shi, Osaka, Japan, 5898511
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine recommended dose for Phase 2 study of CT-322	Within the first 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
To assess the presence of anti CT-322 antibodies	Cycle 1: Day 1, 15, 22 and 29
To assess the presence of anti CT-322 antibodies	Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: June 10, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): February 7, 2012
• Last Update Submitted That Met QC Criteria: February 6, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: CA196-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No