NCT00093873

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2003

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

2.6 years

First QC Date

October 6, 2004

Last Update Submit

May 13, 2013

Conditions

Tumors

Keywords

CancerantiangiogenesisSolid Tumors

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity

    Cycle 1

Secondary Outcomes (1)

  • Dose selection

    Study completion

Study Arms (1)

AMG 706

EXPERIMENTAL

AMG 706 QD

Drug: Anti-angiogenesisDrug: AMG 706

Interventions

Anti-angiogenesisDRUG

Anti-angiogenesis

AMG 706
AMG 706DRUG

Anti-angiogenesis

AMG 706

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 patients with advanced solid tumors. J Clin Oncol. 2007 Jun 10;25(17):2369-76. doi: 10.1200/JCO.2006.07.8170.

    PMID: 17557949RESULT

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Angiogenesis Inhibitorsmotesanib diphosphate

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating AgentsGrowth SubstancesPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesGrowth InhibitorsAntineoplastic AgentsTherapeutic Uses

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Study Start

July 1, 2003

Primary Completion

February 1, 2006

Study Completion

December 1, 2006

Last Updated

May 15, 2013

Record last verified: 2013-05