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NCT00093873 Clinical Trial

Study Evaluating AMG 706 in Subjects With Advanced Solid Tumors

Tumors Clinical Trial

Official title:
A Phase 1, First in Human, Open-Label, Dose Finding Study Evaluating the Safety and Pharmacokinetics of AMG 706 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00093873
Other study ID # 20030116
Secondary ID
Status Completed
Phase Phase 1
First received October 6, 2004
Last updated May 13, 2013
Start date July 2003
Est. completion date December 2006

Study information
Verified date May 2013
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will determine the safety and pharmacokinetics of AMG 706 in subjects with advanced solid tumors.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date December 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Anti-angiogenesis
Anti-angiogenesis
• AMG 706
Anti-angiogenesis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & Publications (1)

Rosen LS, Kurzrock R, Mulay M, Van Vugt A, Purdom M, Ng C, Silverman J, Koutsoukos A, Sun YN, Bass MB, Xu RY, Polverino A, Wiezorek JS, Chang DD, Benjamin R, Herbst RS. Safety, pharmacokinetics, and efficacy of AMG 706, an oral multikinase inhibitor, in p — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Dose limiting toxicity Cycle 1 Yes
Secondary Dose selection Study completion No
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