Study of AMG 706 in Subjects With Advanced Gastrointestin... | NCT00089960

Studies
Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)

NCT00089960

Sponsor

Amgen

Status

Completed

Last Update Posted

Apr 29, 2013Estimated

Enrollment

138Actual

Phase

Phase 2

Conditions

Gastrointestinal Cancer

Interventions

AMG 706

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Yes

Start Date

Oct 2004

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2008Actual

First Submitted Date

Aug 18, 2004

First Submission Date that Met QC Criteria

Aug 19, 2004

First Posted Date

Aug 20, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2013

Last Update Posted Date

Apr 29, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Label	Type	Description	Intervention Names
Arm	Other	AMG 125 mg daily continuously	Drug: AMG 706

Name	Type	Description	Arm Group Labels	Other Names
AMG 706	Drug	AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.	Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate as defined using modified RECIST criteria.		48 weeks treatment or until progressive disease, or unacceptable toxicity

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival		time from randomization to progressive disease
Overall survival		time to death
Time to progression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.

Exclusion criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20838998	Result	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.

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases