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

Phase 1

Completed

• Conditions: Tumors; Neoplasm Metastasis
• Interventions: Drug: Brivanib; Drug: Brivanab

• Registration Number: NCT00207103
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2007-10
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-03
• Last Update Posted: 2008-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Brivanib	-
2	Brivanib	-
4	Brivanib	-
3	Brivanib	-
6	Brivanab	-
5	Brivanib	-

Primary Outcome Measures

Name	Time	Method
Safety assessment	throughout the study
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
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

Secondary Outcome Measures

Name	Time	Method
Efficacy based on duration of response and time to progression based on assessment	measured every 8 weeks throughout the study

Trial Locations

Locations (4)

Premiere Oncology; 🇺🇸 Santa Monica, California, United States

University Of Wisconsin Comprehensive Center; 🇺🇸 Madison, Wisconsin, United States

Local Institution; 🇬🇧 Manchester, Greater Manchester, United Kingdom

Indiana University Med Center; 🇺🇸 Indianapolis, Indiana, United States