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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329004
• Other study ID #: CA187-002
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2006
• Last updated: January 24, 2011
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cancer
• Tumor

Intervention

Drug:
• BMS-690514
Tablets, Oral, up to 300 mg, once daily, up to 24 mos

Locations

Country	Name	City	State
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Toronto	Ontario
France	Local Institution	Toulouse
France	Local Institution	Villejuif
Spain	Local Institution	Barcelona
United States	The University Of Texas Md Anderson Cancer Center	Houston	Texas
United States	Indiana University Med Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks	Yes
Primary	Highest dose tolerated		continuous medical review of adverse event reports	Yes
Secondary	Effective dose or doses of BMS-690514		tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports	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
•   Investigator Inquiry form