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

Gastrointestinal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089960
• Other study ID #: 20040110
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2004
• Last updated: April 25, 2013
• Start date: October 2004
• Est. completion date: June 2008

Study information

• Verified date: April 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Benjamin RS, Schöffski 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate as defined using modified RECIST criteria.		48 weeks treatment or until progressive disease, or unacceptable toxicity	No
Secondary	Progression-free survival		time from randomization to progressive disease	No
Secondary	Overall survival		time to death	No
Secondary	Time to progression		time from response to progressive disease	No
Secondary	Time to response		time from first treatment to response	No
Secondary	Patient-reported outcomes		quality of life	No
Secondary	Use of opioid analgesics after minimal 6 months treatment		narcotics usage during study	No
Secondary	Objective response by PET and tumor size/density changes at week 8		response rate at week 8	No
Secondary	Objective response by size changes and/or target tumor density changes at week 8		response rate at week 8	No
Secondary	Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related)		for duration of study	Yes
Secondary	Duration of response		time to respone to progression	No
Secondary	Palliative response		amelioration of symptoms	No
Secondary	Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships		during specific study timepoints	No

External Links

•   AmgenTrials clinical trials website