Gastrointestinal Stromal Tumor (GIST)Phase 2NCT00867113

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

A Phase 2 study testing imatinib mesylate in people with Gastrointestinal Stromal Tumor (GIST), run by Novartis Pharmaceuticals at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Stromal Tumor (GIST)
What is being tested?: imatinib mesylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 21 sitesUnited States
Study dates: 22 Jul 2009to 20 Dec 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.
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:
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.
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.
Written, voluntary informed consent.

Who cannot join

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.

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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.
-

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

University Cancer & Blood Center, LLC
Athens, Georgia, 30607
University of Colorado University of Colorado
Aurora, Colorado, 80045
Dana Farber Cancer Institute Dana-Farber
Boston, Massachusetts, 02215
Kootenai Medical Center Kootenai Cancer Cancer
Coeur d'Alene, Idaho, 83814
Karmanos Cancer Institute Karmonos Cancer Instit. (40)
Detroit, Michigan, 48201
Duke University Medical Center Duke University Med Ctr (8)
Durham, North Carolina, 27710
North Shore University Health System
Evanston, Illinois, 60201
Longstreet Cancer Center
Gainesville, Georgia, 30501
Penn State University / Milton S. Hershey Medical Center Penn Stat University
Hershey, Pennsylvania, 17033-0850
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (4)
Houston, Texas, 77030
Kingport Hematology Oncology
Kingsport, Tennessee, 37660
University of California San Diego - Moores Cancer Center Moores UCSD Cancer Center (31)
La Jolla, California, 92093-0658
Southern Nevada Cancer Research Foundation S. Nevada Cancer Res (2)
Las Vegas, Nevada, 89106
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (7)
New York, New York, 10021
Virginia Oncology Associates Viriginia Oncology Assoc.
Norfolk, Virginia, 23502
Oregon Health & Science University OHS University
Portland, Oregon, 97239
Roger Williams Medical Center Medical Center
Providence, Rhode Island, 02908
South Texas Oncology and Hematology, PA South Texas Onc/Hem
San Antonio, Texas, 78259
Washington University School of Medicine Center for Advanced Medicine
St Louis, Missouri, 63110
Washington Hospital Center Department of Medical Oncology
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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)

Read the 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.

Conditions: Gastrointestinal Stromal Tumor (GIST)
Being tested: imatinib mesylate
Keywords: Imatinib, Protein Kinase Inhibitors, Gastrointestinal Stromal Tumors, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Adjuvant, PERSIST, PERSIS-5
Medical subject headings: Gastrointestinal Stromal Tumors, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

imatinib mesylateDrug
imatinib mesylate was supplied in 100 and 400 mg tablets

Study groups in NCT00867113
Study group	Role	What they receive
Imatinib	Experimental	All subjects received in tablet form imatinib (STI571) 400 mg once daily. Receives: Drug: imatinib mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: Baseline up to 60 months

Secondary outcomes (2)

Overall Survival (OS) at 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.
Measured: Baseline up to approximately 60 months
Kaplan-Meier Estimates for Overall Survival (OS) up to 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.
Measured: Baseline up to appoximately 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 200920 Dec 2016

First posted23 Mar 2009 (estimated)
Study start22 Jul 2009
Primary completion20 Dec 2016
Study completion20 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gastrointestinal Stromal Tumor (GIST)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00867113
Sponsor's protocol ID: CSTI571BUS282
Status last verified: Mar 2018
First submitted: 20 Mar 2009
Last updated: 14 Mar 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 30383140
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.
PubMed 21387287

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00867113
Acronym / sponsor ID: CSTI571BUS282
Conditions: Gastrointestinal Stromal Tumor (GIST)
Keywords: Imatinib, Protein Kinase Inhibitors, Gastrointestinal Stromal Tumors, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Adjuvant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 22 Jul 2009 (actual)
Primary completion: 20 Dec 2016 (actual)
Study completion: 20 Dec 2016 (actual)
First posted: 23 Mar 2009 (estimated)
Results: Posted 14 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Imatinib	Experimental	Drug: imatinib mesylateAll subjects received in tablet form imatinib (STI571) 400 mg once daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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:
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.

Key exclusion criteria (9 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
imatinib mesylateimatinib mesylate was supplied in 100 and 400 mg tablets	Drug	Imatinib

Primary outcome

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

2 secondary outcomes

Overall Survival (OS) at 60 Months
Time frame: Baseline up to approximately 60 months
Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
Time frame: Baseline up to appoximately 60 months

Results and safety

Results posted to the registry on 14 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Imatinib	91	46

Primary outcome: Recurrence-free Survival up to 60 Months

Time frame: Baseline up to 60 months. Number. Unit: participants with an event

Measure	Imatinib n = 91
Subject with an event	9
Event = disease recurrence	7
Event=death	2
Subjects censored	82

Primary outcome: Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months

Time frame: Baseline up to 60 months. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Imatinib n = 91
12 months	97.7 (91.1 to 99.4)
18 months	97.7 (91.1 to 99.4)
24 months	96.5 (89.6 to 98.9)
36 months	95.1 (87.5 to 98.2)
48 months	95.1 (87.5 to 98.2)
60 months	90.1 (80.0 to 95.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Imatinib	28 of 91 (30.8%)	91 of 91 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30383140Raut 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.
Derived from this study: PubMed 21387287Essat 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.
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate in people with Gastrointestinal Stromal Tumor (GIST), run by Novartis Pharmaceuticals at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free Survival up to 60 Months (time frame: Baseline up to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00867113, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.