A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Cancer; Tumor
• Interventions: Drug: BMS-690514

• Registration Number: NCT00329004
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-24
• Study Start: 2006-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Men and women 18 and older
• Diagnosis of any solid tumor
• ECOG performance status score 0-1
• Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
• Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)

Exclusion Criteria

• Treatment with other TKIs within the past 4 weeks
• Patients with brain metastasis
• Patients with centrally located squamous cell carcinoma of the lung
• Major gastrointestinal surgery which may affect absorption of the drug
• Any surgery within last 4 weeks
• History of thromboembolism
• Severe unmanageable diarrhea
• Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
• Part B/Cohort I erlotinib-naive subjects
• Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BMS-690514	-

Primary Outcome Measures

Name	Time	Method
Safety	results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
Highest dose tolerated	continuous medical review of adverse event reports

Secondary Outcome Measures

Name	Time	Method
Effective dose or doses of BMS-690514	tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports

Trial Locations

Locations (3)

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

The University Of Texas Md Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Local Institution; 🇪🇸 Barcelona, Spain