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

Phase 1CompletedNCT00207103

Bristol-Myers Squibb68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumors Neoplasm Metastasis

Interventions

BrivanibDRUG

Tablets, Oral, 180 mg, once daily, until disease progression

BrivanibDRUG

Tablets, Oral, 320 mg, once daily, until disease progression

BrivanibDRUG

Tablets, Oral, 600 mg, once daily, until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (8)

Premiere Oncology

Santa Monica, California, United States

Indiana University Med Center

Indianapolis, Indiana, United States

University Of Wisconsin Comprehensive Center

Madison, Wisconsin, United States

Local Institution

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Safety assessment

Time frame: throughout the study

dose-limiting toxicity (DLT)

Time frame: 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)

Time frame: 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 Outcomes

Efficacy based on duration of response and time to progression based on assessment

Time frame: measured every 8 weeks throughout the study

Data from ClinicalTrials.gov

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