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
  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:


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:
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 April 15, 2014