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

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ClinicalTrials.gov Identifier: NCT00867113
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

March 20, 2009
March 23, 2009
December 15, 2017
March 14, 2018
March 14, 2018
July 22, 2009
December 20, 2016   (Final data collection date for primary outcome measure)
  • Recurrence-free Survival up to 60 Months [ Time Frame: Baseline up to 60 months ]
    Recurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).
  • Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months [ Time Frame: Baseline up to 60 months ]
    Recurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated
Time to recurrence [ Time Frame: Five years ]
Complete list of historical versions of study NCT00867113 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) at 60 Months [ Time Frame: Baseline up to approximately 60 months ]
    Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
  • Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months [ Time Frame: Baseline up to appoximately 60 months ]
    Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
safety and tolerability of five year adjuvant therapy with imatinib [ Time Frame: Five years ]
Not Provided
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Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
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 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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor (GIST)
Drug: imatinib mesylate
imatinib mesylate was supplied in 100 and 400 mg tablets
Experimental: Imatinib
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
Intervention: Drug: imatinib mesylate
Essat M, Cooper K. Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int J Cancer. 2011 May 1;128(9):2202-14. doi: 10.1002/ijc.25827. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
133
December 20, 2016
December 20, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients 18 years of age or older.
  2. Patient must have had a histological diagnosis of primary GIST.
  3. The tumor must expressed KIT (CD117) protein by immunohistochemistry performed by central pathology.
  4. Patient must have been 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 had 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 have been performed within 8 weeks prior to first dose of imatinib study drug.
  7. Performance status 0 or 1 (ECOG)
  8. Patient must had 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 had 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 had negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must have jagreed 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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00867113
CSTI571BUS282
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP