Gastrointestinal Stromal TumorsPhase 3NCT00293124
Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors
A Phase 3 study testing Glivec in people with Gastrointestinal Stromal Tumors, run by Central European Cooperative Oncology Group at 16 sites in 10 countries.
Trial summary
The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data. Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Glivec
- How many people
- 125 participants
- Where
- 16 sitesin 10 countries
- Study dates
- Mar 2004to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Histologically documented diagnosis of GIST which is malignant as well as unresectable (=not amenable to surgery with curative intent) and/or metastatic and therefore incurable Immunohistochemical documentation of c-kit (CD117) expression by tumor
- At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria) which has not been previously embolised or irradiated
- Performance status 0,1, 2 or 3 (ECOG)
- Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L
- Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
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- Life expectancy of at least 6 months
- Written, voluntary, informed consent
- Patients who were previously treated with chemotherapy will be eligible for this study
- Patient who are at least 5 years free of melanoma will be eligible for this study
Who cannot join
- Patient has received any other investigational agents within 28 days of first day of study drug dosing
- Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention and CECOGs' approval is obtained, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
- 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)
- Female patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
- Patient has a known brain metastasis
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- Patient has an acute or known chronic liver disease (i.e., chronic active hepatitis, cirrhosis)
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
- Patient received chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin-C) prior to study entry
- Patient previously received radiotherapy to >= 25 % of the bone marrow
- Patient had a major surgery within 2 weeks prior to study entry
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
- Therapeutic anticoagulation with warfarin (e.g. Coumadin® or Coumadine®)
Trial locations and contacts
16 sites in 10 countries.
16 sites in 10 countries
Bulgaria3 sites
SBALO National Oncology Center
Sofia, 1527
National Oncological Center Hospital
Sofia
Sofia Cancer Center compl. Mladost ,
Sofia
Romania3 sites
Institutul Oncologic Bucuresti
Bucharest
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Emergency Clinical County Hospital , Clin Oncol. Dep
Craiova
Croatia2 sites
Clinical Hospital Split, Center of Oncology
Split
University Hospital Rebro
Zagreb
Czechia2 sites
FN Bulovka
Prague, 186 00
Radioterapeticko-onkologicke. Oddeleni FN Motol
Prague
Bosnia and Herzegovina1 site
Institute of Oncology Sarajevo
Sarajevo
About this study
Official title: An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.
The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data.
Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries.
Read the detailed description
This is a multicenter open label clinical trial to be performed in patients with incurable malignant GISTs that are unresectable or metastatic. Approximately 150 patients will enter the trial.
Patients will receive Imatinib 400 mg p.o./day for a period of up to 24 months provided that in the opinion of the investigator the patient is benefiting from treatment with Imatinib, and in the absence of any safety concerns.
Treatment after completion of the 24 months study is at the discretion of the investigator. Imatinib should be increased to 600 mg p.o./day and then to 400 mg b.i.d if the patient is progressing on the respective dose level.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Glivec
- Keywords
- Gastrointestinal Stromal Tumors, Glivec
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlivecDrug
400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
Measured: until PD
Secondary outcomes (2)
Time to Disease Progression
Measured: until PD
Overall Survival
Measured: until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startMar 2004
- Primary completionJul 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Brodowicz, MD, Principal investigator, University Clinic of Internal Medicine I / Clinical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293124
- Sponsor's protocol ID
- CECOG/GIST 1.2.001
- Other IDs
- CSTI571BIC07
- Status last verified
- May 2012
- First submitted
- 16 Feb 2006
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.
- ClinicalTrials.gov ID
- NCT00293124
- Acronym / sponsor ID
- CECOG/GIST 1.2.001
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors, Glivec
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Central European Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data.
Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries.
Detailed description
This is a multicenter open label clinical trial to be performed in patients with incurable malignant GISTs that are unresectable or metastatic. Approximately 150 patients will enter the trial.
Patients will receive Imatinib 400 mg p.o./day for a period of up to 24 months provided that in the opinion of the investigator the patient is benefiting from treatment with Imatinib, and in the absence of any safety concerns.
Treatment after completion of the 24 months study is at the discretion of the investigator. Imatinib should be increased to 600 mg p.o./day and then to 400 mg b.i.d if the patient is progressing on the respective dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients >= 18 years of age
- Histologically documented diagnosis of GIST which is malignant as well as unresectable (=not amenable to surgery with curative intent) and/or metastatic and therefore incurable Immunohistochemical documentation of c-kit (CD117) expression by tumor
- At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria) which has not been previously embolised or irradiated
- Performance status 0,1, 2 or 3 (ECOG)
- Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L
Key exclusion criteria (13 listed)
- Patient has received any other investigational agents within 28 days of first day of study drug dosing
- Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention and CECOGs' approval is obtained, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
- 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)
- Female patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal 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 |
|---|---|---|
| Glivec400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing | Drug | – |
Primary outcome
Time to Disease Progression
Time frame: until PD
2 secondary outcomes
Time to Disease Progression
Time frame: until PD
Overall Survival
Time frame: until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Related InfoLink 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.
Thomas Brodowicz, MD principal investigator
University Clinic of Internal Medicine I / Clinical Oncology
16 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glivec in people with Gastrointestinal Stromal Tumors, run by Central European Cooperative Oncology Group at 16 sites in 10 countries.
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 10 inclusion and 13 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Bulgaria, Romania, Croatia, Czechia, Austria and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Disease Progression (time frame: until PD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2015.