Japanese Phase 1 Study of BMS-844203 (CT322)

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01146171
• Other study ID #: CA196-007
• Status: Withdrawn
• Phase: Phase 1
• First received: June 10, 2010
• Last updated: February 6, 2012
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• BMS-844203 (CT-322)
Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent

Locations

Country	Name	City	State
Japan	Local Institution	Osaka-Sayama-Shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine recommended dose for Phase 2 study of CT-322		Within the first 28 days	Yes
Secondary	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	No
Secondary	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	No
Secondary	To assess anti-tumor activity of CT-322		Every 8 weeks	No
Secondary	To assess the effects of CT-322 on plasma VEGF levels		Cycle 1: Day 1, 3, 8, 15, 22	No
Secondary	To assess the effects of CT-322 on plasma VEGF levels		Cycle 3: Day 1	No
Secondary	To assess the presence of anti CT-322 antibodies		Cycle 1: Day 1, 15, 22 and 29	Yes
Secondary	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	Yes

External Links

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