Advanced Gastrointestinal Stromal TumorsPhase 2NCT00940563
A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors
A Phase 2 study testing Imatinib in people with Advanced Gastrointestinal Stromal Tumors, run by Novartis Pharmaceuticals at 26 sites in Italy.
Trial summary
Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastrointestinal Stromal Tumors
- What is being tested?
- Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 26 sitesItaly
- Study dates
- Mar 2002to Aug 2004
- Phase
- Phase 2
- 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, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
- Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
- At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
- Performance status 0,1, 2 or 3 (ECOG).
- Adequate end organ function.
- Adequate bone marrow function.
- Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
Who cannot join
- Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- Other primary malignancy with < 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
- Pregnancy, breast-feeding.
- Severe and/or uncontrolled medical disease.
- Known brain metastasis.
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- Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
- Previous radiotherapy to ≥ 25 % of the bone marrow.
- Major surgery within 2 weeks prior to study entry.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Italy26 sites
Novartis Investigative Site
Ancona
Novartis Investigative Site
Aviano
Novartis Investigative Site
Bari
Novartis Investigative Site
Bergamo
Novartis Investigative Site
Bologna
Novartis Investigative Site
Candiolo
Novartis Investigative Site
Ferrara
Novartis Investigative Site
Florence
Novartis Investigative Site
Genova
Novartis Investigative Site
Livorno
Novartis Investigative Site
Meldola
Novartis Investigative Site
Messina
Novartis Investigative Site
Milan
Novartis Investigative Site
Monserrato
Novartis Investigative Site
Naples
Novartis Investigative Site
Nola
Novartis Investigative Site
Padova
Novartis Investigative Site
Palermo
Novartis Investigative Site
Perugia
Novartis Investigative Site
Pisa
Novartis Investigative Site
Ravenna
Novartis Investigative Site
Roma
Novartis Investigative Site
Rozzano
Novartis Investigative Site
Sassari
Novartis Investigative Site
Torino
Novartis Investigative Site
Verona
About this study
Official title: STI571 (Imatinib) in KIT-expressing Gastrointestinal Stromal Tumors (GIST): a Prospective, Open-label, Multicenter Study on Best Clinical Use in the Advanced Disease.
Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.
- Conditions
- Advanced Gastrointestinal Stromal Tumors
- Being tested
- Imatinib
- Keywords
- GIST, imatinib, advanced GIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Imatinib | Experimental | Not described Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response /RecIST criteria)
Measured: first 2 months monthly, then every 3 months
Secondary outcomes (4)
SAE and tolerability profile
Measured: ongoing basis
OS, DFS
Measured: 12 months
effects of the therapy when combined with other treatment modalities i.e. surgery of residual disease.
Measured: 12 months
which early predictive factors of tumor response may be of relevance, i.e. conventional pathologic characteristics of tumor and radiological aspects.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startMar 2002
- Primary completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal Stromal TumorsStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940563
- Sponsor's protocol ID
- CSTI571BIT03
- Status last verified
- Jun 2011
- First submitted
- 26 Jun 2009
- Last updated
- 1 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STI571 (Imatinib) in KIT-expressing Gastrointestinal Stromal Tumors (GIST): a Prospective, Open-label, Multicenter Study on Best Clinical Use in the Advanced Disease.
- ClinicalTrials.gov ID
- NCT00940563
- Acronym / sponsor ID
- CSTI571BIT03
- Conditions
- Advanced Gastrointestinal Stromal Tumors
- Keywords
- GIST, imatinib, advanced GIST
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Aug 2004 (actual)
- First posted
- 16 Jul 2009 (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.
Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.
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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years of age.
- Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
- Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
- At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
- Performance status 0,1, 2 or 3 (ECOG).
Key exclusion criteria (11 listed)
- Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- Other primary malignancy with < 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
- Pregnancy, breast-feeding.
- Severe and/or uncontrolled medical disease.
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 | Drug | Imatinib |
Primary outcome
tumor response /RecIST criteria)
Time frame: first 2 months monthly, then every 3 months
4 secondary outcomes
SAE and tolerability profile
Time frame: ongoing basis
OS, DFS
Time frame: 12 months
effects of the therapy when combined with other treatment modalities i.e. surgery of residual disease.
Time frame: 12 months
which early predictive factors of tumor response may be of relevance, i.e. conventional pathologic characteristics of tumor and radiological aspects.
Time frame: 12 months
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 1 Jul 2011.
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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
26 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 in people with Advanced Gastrointestinal Stromal Tumors, run by Novartis Pharmaceuticals at 26 sites in Italy.
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 8 inclusion and 11 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 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy. 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?
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?
tumor response /RecIST criteria) (time frame: first 2 months monthly, then every 3 months). 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 1 Jul 2011; AzTrials last refreshed its copy on 6 Nov 2026.