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

NCT00867113 | Completed Phase 2 Results

• 1 other identifier: CSTI571BUS282
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Gastrointestinal Stromal Tumor (GIST)

Keywords

Imatinib; Protein Kinase Inhibitors; Gastrointestinal Stromal Tumors; Digestive System Diseases; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Adjuvant; PERSIST; PERSIS-5

Outcome Measures

Primary Outcomes (2)

• Recurrence-free Survival 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).

  Baseline up to 60 months

• Kaplan-Meier Estimates for Recurrence-free Survival 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

  Baseline up to 60 months

Secondary Outcomes (2)

• Overall Survival (OS) at 60 Months

  Baseline up to approximately 60 months

• Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months

  Baseline up to appoximately 60 months

Study Arms (1)

Imatinib

EXPERIMENTAL

All subjects received in tablet form imatinib (STI571) 400 mg once daily.

Drug: imatinib mesylate

Interventions

imatinib mesylate DRUG

imatinib mesylate was supplied in 100 and 400 mg tablets

Imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older.
• Patient must have had a histological diagnosis of primary GIST.
• The tumor must expressed KIT (CD117) protein by immunohistochemistry performed by central pathology.
• 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
• 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.
• Performance status 0 or 1 (ECOG)
• 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
• If patient is a cancer survivor, ALL of the following criteria apply:

You may not qualify if:

• Patient has metastatic GIST to the peritoneum, liver, lymph node, or other sites or recurrent GIST.
• Prior treatment for GIST with the exception of prior treatment with imatinib adjuvant lasting ≤ 8 weeks following gross surgical resection.
• Patient has received any other investigational agents within 28 days of first day of study drug dosing.
• 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)
• 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).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin).
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (21)

University of California San Diego - Moores Cancer Center Moores UCSD Cancer Center (31)

La Jolla, California, 92093-0658, United States

Location

University of Colorado University of Colorado

Aurora, Colorado, 80045, United States

Location

Washington Hospital Center Department of Medical Oncology

Washington D.C., District of Columbia, 20010, United States

Location

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

Location

Longstreet Cancer Center

Gainesville, Georgia, 30501, United States

Location

Kootenai Medical Center Kootenai Cancer Cancer

Coeur d'Alene, Idaho, 83814, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Dana Farber Cancer Institute Dana-Farber

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute Karmonos Cancer Instit. (40)

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine Center for Advanced Medicine

St Louis, Missouri, 63110, United States

Location

Southern Nevada Cancer Research Foundation S. Nevada Cancer Res (2)

Las Vegas, Nevada, 89106, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (7)

New York, New York, 10021, United States

Location

Duke University Medical Center Duke University Med Ctr (8)

Durham, North Carolina, 27710, United States

Location

Oregon Health & Science University OHS University

Portland, Oregon, 97239, United States

Location

Penn State University / Milton S. Hershey Medical Center Penn Stat University

Hershey, Pennsylvania, 17033-0850, United States

Location

Roger Williams Medical Center Medical Center

Providence, Rhode Island, 02908, United States

Location

Kingport Hematology Oncology

Kingsport, Tennessee, 37660, United States

Location

MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (4)

Houston, Texas, 77030, United States

Location

South Texas Oncology and Hematology, PA South Texas Onc/Hem

San Antonio, Texas, 78259, United States

Location

Virginia Oncology Associates Viriginia Oncology Assoc.

Norfolk, Virginia, 23502, United States

Location

Related Publications (2)

• Raut CP, Espat NJ, Maki RG, Araujo DM, Trent J, Williams TF, Purkayastha DD, DeMatteo RP. Efficacy and Tolerability of 5-Year Adjuvant Imatinib Treatment for Patients With Resected Intermediate- or High-Risk Primary Gastrointestinal Stromal Tumor: The PERSIST-5 Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e184060. doi: 10.1001/jamaoncol.2018.4060. Epub 2018 Dec 13.

  PMID: 30383140 DERIVED

• 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.

  PMID: 21387287 DERIVED

Related Links

• Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Digestive System Diseases; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: July 22, 2009
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: March 14, 2018
• Results First Posted: March 14, 2018

Record last verified: 2018-03

Locations

US (21)