MDACC Study Summary 2004-0537 (Archived)

Study Summary
No. 2004-0537:.......Sarcoma......Robert S. Benjamin......Sarcoma Medical Oncology

Study Summary Title



Study Summary Number:	2004-0537

Study 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

Physician

New Patient Referral



Name:	Robert S. Benjamin	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Sarcoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3626 Contact us about clinical trials

General Information



Disease Group:	Sarcoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every other week for the first 16 weeks, then every 4 weeks after the first 16 weeks, or more often if clinically indicated. Then a follow up visit 2 weeks after last dose of AMG 706 if progressive disease.

Treatment Agents:	AMG 706	Home Care:	The oral medication may be taken at home by the patient.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Not applicable.


Description/ Intervention:	The goal of this clinical research study is to test the safety and effectiveness of AMG 706 in patients with gastrointestinal stromal tumors (GIST) that have not been controlled while taking imatinib mesylate (Gleevec Ž).

Study Objectives / Outcomes

Primary Objective:

To evaluate the treatment effect of AMG 706 on the objective response rate as assessed by modified RECIST criteria in subjects with advanced GISTs who developed progressive disease or relapsed per modified RECIST while on imatinib mesylate.

Secondary Objectives:

To assess the treatment effect of AMG 706 on duration of response, progression-free survival, time to disease progression, time to response, and overall survival.
To explore patient-reported outcomes, performance status, palliative response, and opioid analgesic use with AMG 706 treatment.
To explore the utility of using ¹⁸FDG-PET scan at week 8 and target tumor size and density changes at week 8 (from CT scan) for the prediction of tumor response.
To assess PK profiles of AMG 706.
To assess the safety profile of AMG 706 in subjects with GIST.

Study Status Information



Study Activation / Registration Date:	12/27/2004

IRB Review and Approval Date:	09/15/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	100

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Men and women >/= 18 years of age with histologically confirmed GIST (CD117 positive).

2) Subjects must have documented treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks.

3) Presence of at least one measurable (per modified RECIST) and progressing tumor lesion that has not been previously treated with radiotherapy or embolization, and that can be evaluate by contrast enhanced CT or MRI.

4) Subject must be off imatinib mesylate for at least 7 days before study day 1 (imatinib mesylate washout).

5) Must have documented disease progression during previous treatment with at least 600 mg imatinib mesylate. Prestudy disease progression (as defined by modified RECIST) is an increase of >/= 20% in sum of longest diameter (LD) of target lesions, taking as reference smallest sum LD, or new lesion(s). The period of time covered by the 2 CT scans which demonstrate disease progression may include treatment with 400 mg, but must include at least 8 wks of treatment with at least 600 mg imatinib, and include radiographic evidence of continued tumor growth >/= 10% sum LD during treatment with 600 mg.

6) Karnofsky performance status of >/= 60.

7) Before any study specific procedure, the appropriate written informed consent must be obtained.

8) Patients cases will be presented at Sarcoma Mulidisciplinary Conference.

Exclusion Criteria:

1) Symptomatic central nervous system tumor involvement.

2) 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.

3) Myocardial infarction, or unstable or uncontrolled disease or condition related to or impacting cardiac function (eg. unstable angina, congestive heart failure [New York Heart Association > class II]) within one year of study day 1.

4) Uncontrolled hypertension as defined by systolic BP > 145 mmHg or diastolic BP > 85 mmHg. Patients on antihypertensive medication must meet these parameters on a stable antihypertensive medication regimen.

5) History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1.

6) Recent major surgical procedure (within 28 days of study day 1).

7) Absolute neutrophil (ANC) < 1.5 x 10*9/L, platelet count < 100,000 x 10*9/L (without transfusion within 2 weeks of study day 1), hemoglobin < 9 g/dl.

8) Serum creatinine > 2.0 mg/dL, urine protein quantitative value of > 1+ on dipstick, >/= 30 mg/dl in urinalysis, or > 500 mg in 24 hour urine collection.

9) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 X upper limits of normal (ULN), or AST or ALT > 5 x ULN if secondary to liver metastases.

10) Alkaline phosphatase > 2.5 x ULN, or alkaline phosphatase > 5 x ULN in the presence of bone or liver metastases. Total bilirubin > 2 x ULN.

11) Previous exposure to AMG 706 or other tyrosine kinase inhibitors of c-kit (except imatinib mesylate) or VEGF (vascular endothelial growth factor) type (eg, SU5416, SU6668, SU11248, PTK787).

12) Coumarin-type anticoagulants (including warfarin) > 2 mg/day must not be administered within 7 days before study day 1.

13) Other investigational procedures are excluded.

14) Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).

15) Subject of child-bearing potential is evidently pregnant (eg. positive HCG test) or is breast feeding.

16) Subject is not using adequate contraceptive precautions.

17) Subject has known sensitivity to any of the products to be administered during dosing.

18) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

19) Currently or previously treated with rifampin or phenobarbitol (within 14 days of study day 1) or ketoconazole, itraconazole, erythromycin, clarithromycin, nefazodone, cyclosporine, tacrolimus, and any HIV protease inhibitor (within 7 days of study day 1).

20) There may be no concurrent therapy with St. John's Wort.

Links

Registration Number: NCT00089960
Study Information on Clinical Trials Registry (clinicaltrials.gov)