NCT00254267

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_2

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

November 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

November 14, 2005

Last Update Submit

February 26, 2014

Conditions

Advanced Gastrointestinal Stromal Tumor

Keywords

Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706

Outcome Measures

Primary Outcomes (1)

  • The objective response rate as assessed by modified RECIST

    Every 8 weeks

Secondary Outcomes (1)

  • Duration of response, progression-free survival, time to response, overall survival, PK and safety profile

    imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter;

Study Arms (1)

Arm One

EXPERIMENTAL

AMG 706 125mg, oral, once a day

Drug: AMG 706

Interventions

AMG 706DRUG

AMG 706 125mg, oral, once a day

Arm One

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of histological confirmed GIST
  • Had prior imatinib mesylate therapy
  • Has at least 1 measurable leasion by modified RECIST

You may not qualify if:

  • Central nervous system tumor involvement requiring treatment
  • History of myocardial infraction
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.

    PMID: 20838998DERIVED

Related Links

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

motesanib diphosphate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 16, 2005

Study Start

November 1, 2005

Primary Completion

February 1, 2007

Study Completion

December 1, 2012

Last Updated

February 27, 2014

Record last verified: 2014-02