MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Neoplasm Metastasis Clinical Trial

Official title:

Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207103
• Other study ID #: CA182-002
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: November 3, 2008
• Start date: September 2004
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors

• No tumor spread to the brain

• Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)

• Available tumor tissue sample from prior surgery

• 4-6 weeks since prior therapy and recovered from prior therapy

• Men and women, ages 18 and above

• Women must not be pregnant or breastfeeding

• Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer

• Measurable disease on scans (at least one)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Tumors

Intervention

Drug:
• Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
• Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
• Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
• Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
• Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
• Brivanab
Tablets, Oral, 1000 mg, once daily, until disease progression

Locations

Country	Name	City	State
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Ottawa	Ontario
Italy	Local Institution	Milano
United Kingdom	Local Institution	Manchester	Greater Manchester
United Kingdom	Local Institution	Middlesex	Greater London
United States	Indiana University Med Center	Indianapolis	Indiana
United States	University Of Wisconsin Comprehensive Center	Madison	Wisconsin
United States	Premiere Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment		throughout the study	Yes
Primary	dose-limiting toxicity (DLT)		assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified	Yes
Primary	determination of maximum tolerated dose (MTD)		during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified	Yes
Secondary	Efficacy based on duration of response and time to progression based on assessment		measured every 8 weeks throughout the study	No

External Links

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