NCT00089960

Brief Summary

This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2004

Typical duration 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

First Submitted

Initial submission to the registry

August 18, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2004

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

August 18, 2004

Last Update Submit

April 25, 2013

Conditions

Gastrointestinal Cancer

Keywords

GIST

Outcome Measures

Primary Outcomes (1)

  • Objective response rate as defined using modified RECIST criteria.

    48 weeks treatment or until progressive disease, or unacceptable toxicity

Secondary Outcomes (12)

  • Progression-free survival

    time from randomization to progressive disease

  • Overall survival

    time to death

  • Time to progression

    time from response to progressive disease

  • Time to response

    time from first treatment to response

  • Patient-reported outcomes

    quality of life

  • +7 more secondary outcomes

Study Arms (1)

Arm

OTHER

AMG 125 mg daily continuously

Drug: AMG 706

Interventions

AMG 706DRUG

AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.

Arm

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years;
  • Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;
  • Presence of at least one measurable (per RECIST)
  • Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);
  • Karnofsky performance status ≥ 60;
  • imatinib treatment terminated at least 7 days before study day 1;
  • Adequate hepatic, renal, and cardiac function.

You may not qualify if:

  • Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class \> II),
  • uncontrolled hypertension (systolic \> 145 mmHg or diastolic \> 85 mmHg),
  • History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;
  • Absolute neutrophil count \< 1.5x109/L, platelet count \< 100x109/L, hemoglobin \< 9.0 g/dL;
  • Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.
  • The study was approved by the institutional review board of each participating institution, and all patients provided written informed consent before any study-related procedures were performed.

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: 20838998RESULT

Related Links

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

motesanib diphosphate

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

August 18, 2004

First Posted

August 20, 2004

Study Start

October 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2008

Last Updated

April 29, 2013

Record last verified: 2013-04