BMS-599626 in Treating Patients With Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: BMS-59926

• Registration Number: NCT00093730
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

RATIONALE: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in treating patients with metastatic solid tumors.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose, biologically active dose, and recommended phase II dose(s) of BMS-599626 in patients with metastatic HER2/neu-overexpressing primary solid tumors.

Secondary

* Determine the safety and tolerability of this drug in these patients.

* Determine the pharmacokinetics of this drug in these patients.

* Determine the effect of this drug on biomarkers and predictive markers of HER1 and HER2 in skin and tumor in these patients.

* Evaluate tumor metabolic activity in response to this drug in these patients.

* Determine, preliminarily, evidence of anti-tumor activity of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive oral BMS-599626 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-599626 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 patients are treated at that dose level.

PROJECTED ACCRUAL: Approximately 3-60 patients will be accrued for this study within 1 year.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-10-06
• Study First Submitted QC: 2004-10-07
• Study First Posted: 2004-10-08
• Primary Completion: 2006-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-59926	BMS-59926	-

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose of BMS-599626	28 days

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States