Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00867113
First received: March 20, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.


Condition Intervention Phase
Gastrointestinal Stromal Tumor (GIST)
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to recurrence [ Time Frame: Five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and tolerability of five year adjuvant therapy with imatinib [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: July 2009
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Mesylate
Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST)
Drug: imatinib mesylate
imatinib mesylate 400 mg once per day by mouth for 5 years.
Other Names:
  • Gleevec
  • Glivec

Detailed Description:

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.

  Eligibility

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

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867113

  Show 21 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00867113     History of Changes
Other Study ID Numbers: CSTI571BUS282
Study First Received: March 20, 2009
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Imatinib
Protein Kinase Inhibitors
Gastrointestinal Stromal Tumors
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Adjuvant
PERSIST
PERSIS-5

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Protein Kinase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014