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Study Evaluating AMG 706 in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00093873
First received: October 6, 2004
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Tumors
 Drug: Anti-angiogenesis
Drug: AMG 706
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose selection [ Time Frame: Study completion ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: July 2003
Study Completion Date: December 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 706
AMG 706 QD
 Drug: Anti-angiogenesis
Anti-angiogenesis
Drug: AMG 706
Anti-angiogenesis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093873

Sponsors and Collaborators
Amgen
Investigators
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:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00093873     History of Changes
Other Study ID Numbers: 20030116
Study First Received: October 6, 2004
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Cancer
antiangiogenesis
Solid Tumors

ClinicalTrials.gov processed this record on May 16, 2013