Study Evaluating AMG 706 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00093873

Recruitment Status : Completed

First Posted : October 8, 2004

Last Update Posted : May 15, 2013

Sponsor:

Information provided by (Responsible Party):

Amgen

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Tumors	Drug: Anti-angiogenesis Drug: AMG 706	Phase 1

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	71 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	July 2003
Actual Primary Completion Date :	February 2006
Actual Study Completion Date :	December 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: AMG 706 AMG 706 QD	Drug: Anti-angiogenesis Anti-angiogenesis Drug: AMG 706 Anti-angiogenesis

Outcome Measures

Primary Outcome Measures :

Dose limiting toxicity [ Time Frame: Cycle 1 ]

Secondary Outcome Measures :

Dose selection [ Time Frame: Study completion ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093873

Sponsors and Collaborators

Amgen

Investigators

Layout table for investigator information

Study Director:	MD	Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

Publications of Results:

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 patients with advanced solid tumors. J Clin Oncol. 2007 Jun 10;25(17):2369-76.

Layout table for additonal information

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00093873
Other Study ID Numbers:	20030116
First Posted:	October 8, 2004 Key Record Dates
Last Update Posted:	May 15, 2013
Last Verified:	May 2013

Keywords provided by Amgen:


Cancer antiangiogenesis Solid Tumors

Additional relevant MeSH terms:

Layout table for MeSH terms

Neoplasms Motesanib diphosphate Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

To Top