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A Phase II, Non-Randomized, Open-Label Multicenter Study of 5 Year Adjuvant Imatinib Mesylate (Gleevec®) in Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST)

Phase 2
18 Years
Open (Enrolling)
Gastrointestinal Stromal Tumor (GIST)

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Trial Information

A Phase II, Non-Randomized, Open-Label Multicenter Study of 5 Year Adjuvant Imatinib Mesylate (Gleevec®) in Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST)

This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA.
The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in
patients at significant risk for recurrence following complete resection of primary GIST. A
total of 85 adult patients, 18 years of age and older will be enrolled.Participants will
take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of
the treatment period, patients will be followed for 2 years for survival, status of response
and antineoplastic treatments and quality of life.

Inclusion Criteria:

1. Patients 18 years of age or older.

2. Patient must have a histological diagnosis of primary GIST.

3. The tumor must express KIT (CD117) protein by immunohistochemistry performed by
central pathology.

4. Patient must be at significant risk of tumor recurrence as defined by either:

- Primary GIST (any site): ≥ 2 cm and a mitotic rate of ≥ 5/50 HPF's

- Non-gastric primary GIST: ≥ 5cm

5. Patient must have undergone complete gross resection of a primary GIST within 12
weeks prior to first dose of imatinib study drug. The inclusion of R1 resections will
be reviewed on a case by case basis by the Study Management Committee.

6. Patient must have no evidence of metastatic GIST on either 1) a post-operative CT of
the abdomen and pelvis with intravenous and oral contrast or 2) MRI of the abdomen
and pelvis with intravenous contrast. CT or MRI must be performed within 8 weeks
prior to first dose of imatinib study drug.

7. Performance status 0 or 1 (ECOG)

8. Patient must have the following post-operative laboratory values confirmed within 14
days prior to first dose of imatinib study drug:

- total bilirubin < 1.5 x ULN NOTE: Patients with elevated bilirubin secondary to
Gilbert's disease are eligible to participate in the study.

- ALT and AST < 2.5 x ULN

- creatinine < 1.5 x ULN

- ANC > 1.5 x 109/L

- platelets > 100 x 109/L

9. If patient is a cancer survivor, ALL of the following criteria apply:

- Patient has undergone potentially curative therapy for all prior malignancies.

- No evidence of any prior malignancies for at least 3 years with no evidence of
recurrence (except for effectively treated basal cell or squamous carcinoma of
the skin, carcinoma in-situ of the cervix that has been effectively treated by
surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral
breast treated by surgery alone).

- Patient is deemed by their treating physician to be at low risk for recurrence
from prior malignancies.

10. Female patients of childbearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Female
patients of reproductive potential must agree to employ an effective barrier method
of birth control throughout the study and for up to 7 days following discontinuation
of study drug.

11. Written, voluntary informed consent.

Exclusion Criteria:

1. Patient has metastatic GIST to the peritoneum, liver, lymph node, or other sites or
recurrent GIST.

2. Prior treatment for GIST with the exception of prior treatment with imatinib adjuvant
lasting ≤ 8 weeks following gross surgical resection.

3. Patient has received any other investigational agents within 28 days of first day of
study drug dosing.

4. Patient with Grade III/IV cardiac problems as defined by the New York Heart
Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6
months of study)

5. Patients with severe and/or uncontrolled concurrent medical disease that in the
opinion of the investigator could cause unacceptable safety risk or compromise
compliance with the protocol (i.e., uncontrolled diabetes, chronic renal disease,
chronic liver disease, or active uncontrolled infection).

6. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

7. Patient receiving concurrent treatment with warfarin (acceptable alternative:
low-molecular weight heparin).

8. Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent.


Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to recurrence

Outcome Time Frame:

Five years

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

April 2016

Related Keywords:

  • Gastrointestinal Stromal Tumor (GIST)
  • Imatinib
  • Protein Kinase Inhibitors
  • Gastrointestinal Stromal Tumors
  • Digestive System Diseases
  • Digestive System Neoplasms
  • Gastrointestinal Diseases
  • Gastrointestinal Neoplasms
  • Adjuvant
  • PERSIS-5
  • Gastrointestinal Stromal Tumors



Memorial Sloan Kettering Cancer Center New York, New York  10021
Brigham and Women's Hospital Boston, Massachusetts  02115
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
MD Anderson Cancer Center/University of Texas Houston, Texas  77030
Northeast Georgia Cancer Care Athens, Georgia  30607
University of California San Diego Dept of Moores Cancer Ctr (3) La Jolla, California  92093-0658
Kootenai Medical Center Dept.ofKootenai Med.Ctr. Coeur d'Alene, Idaho  83814
University of Colorado University of Colorado Aurora, Colorado  80045
Washington Hospital Center Department of Medical Oncology Washington, District of Columbia  20010
Longstreet Cancer Center Gainesville, Georgia  30501
North Shore University Health System NorthShore University Evanston, Illinois  60201
Wayne State University/Karmanos Cancer Institute Department of WSU/Karmanos (2) Detroit, Michigan  48201
Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology St. Louis, Missouri  63110
Southern Nevada Cancer Research Foundation S. Nevada Cancer Res (2) Las Vegas, Nevada  89106
Duke University Medical Center Duke University Durham, North Carolina  27710
Oregon Health & Science University OHS University Portland, Oregon  97239
Penn State University / Milton S. Hershey Medical Center Penn Stat University Hershey, Pennsylvania  17033-0850
Roger Williams Medical Center Medical Center Providence, Rhode Island  02908
Kingport Hematology Oncology Kingsport, Tennessee  37660
South Texas Oncology and Hematology, PA South Texas Onc/Hem San Antonio, Texas  78259
Virginia Oncology Associates Viriginia Oncology Assoc Norfolk, Virginia  23502