Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00089960

Purpose

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

Condition	Intervention	Phase
Gastrointestinal Cancer	Drug: AMG 706	Phase II

Amgen has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Motesanib

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Objective response rate as defined using modified RECIST criteria. [ Time Frame: 48 weeks treatment or until progressive disease, or unacceptable toxicity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: time from randomization to progressive disease ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: time to death ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: time from response to progressive disease ] [ Designated as safety issue: No ]
Time to response [ Time Frame: time from first treatment to response ] [ Designated as safety issue: No ]
Patient-reported outcomes [ Time Frame: quality of life ] [ Designated as safety issue: No ]
Use of opioid analgesics after minimal 6 months treatment [ Time Frame: narcotics usage during study ] [ Designated as safety issue: No ]
Objective response by PET and tumor size/density changes at week 8 [ Time Frame: response rate at week 8 ] [ Designated as safety issue: No ]
Objective response by size changes and/or target tumor density changes at week 8 [ Time Frame: response rate at week 8 ] [ Designated as safety issue: No ]
Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related) [ Time Frame: for duration of study ] [ Designated as safety issue: Yes ]
Duration of response [ Time Frame: time to respone to progression ] [ Designated as safety issue: No ]
Palliative response [ Time Frame: amelioration of symptoms ] [ Designated as safety issue: No ]
Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships [ Time Frame: during specific study timepoints ] [ Designated as safety issue: No ]

Enrollment:	138
Study Start Date:	October 2004
Study Completion Date:	June 2008
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm AMG 125 mg daily continuously	Drug: AMG 706 AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.

Detailed Description:

Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089960

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00089960 History of Changes
Other Study ID Numbers:	20040110
Study First Received:	August 18, 2004
Last Updated:	January 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

GIST

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012