Gastrointestinal Stromal TumorsPhase 2CONVERTNCT01483014
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
A Phase 2 study testing imatinib mesylate in people with Gastrointestinal Stromal Tumors, run by Novartis Pharmaceuticals at 11 sites in Brazil.
Trial summary
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- imatinib mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesBrazil
- Study dates
- Jun 2008to Jan 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with age between 18 and 80 years
- diagnosis of GIST not previously treated
- Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)
Who cannot join
- presence of metastatic disease
- use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30380-490
Novartis Investivative site
Belo Horizonte
Novartis Investigative Site
Florianópolis, Santa Catarina, 88034-000
Novartis Investivative site
Florianópolis
Novartis Investivative site
Porto Alegre
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20230-130
Novartis Investivative site
Rio de Janeiro
Novartis Investigative Site
São Paulo, São Paulo, 01401-901
Novartis Investigative Site
São Paulo, São Paulo, 01509-900
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Novartis Investivative site
São Paulo
About this study
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- imatinib mesylate
- Keywords
- Gastrointestinal,, stromal,, neoadjuvant,, imatinib,, mesylate,, pre-operatory
- 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.
imatinib mesylateDrug
| Study group | Role | What they receive |
|---|---|---|
| imatinib | Experimental | Not described Receives: Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response using the RECIST criteria
Measured: 16 weeks
Secondary outcomes (4)
Progression free survival
Measured: 16 weeks
Time and duration of response
Measured: 16 weeks
Time to treatment failure
Measured: 16 weeks
Overall survival
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startJun 2008
- Primary completionJan 2012
- Study completionJan 2012
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483014
- Sponsor's protocol ID
- CSTI571BBR10
- Acronym
- CONVERT
- Status last verified
- Nov 2016
- First submitted
- 29 Nov 2011
- Last updated
- 18 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
- ClinicalTrials.gov ID
- NCT01483014
- Acronym / sponsor ID
- CONVERT / CSTI571BBR10
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal,, stromal,, neoadjuvant,, imatinib,, mesylate,, pre-operatory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Dec 2011 (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.
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.
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 mesylate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with age between 18 and 80 years
- diagnosis of GIST not previously treated
- Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)
Key exclusion criteria (3 listed)
- presence of metastatic disease
- use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)
- Other protocol-defined inclusion/exclusion criteria may apply.
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 mesylate | Drug | imatinib |
Primary outcome
Objective response using the RECIST criteria
Time frame: 16 weeks
4 secondary outcomes
Progression free survival
Time frame: 16 weeks
Time and duration of response
Time frame: 16 weeks
Time to treatment failure
Time frame: 16 weeks
Overall survival
Time frame: 16 weeks
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 18 Nov 2016.
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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
11 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 Tumors, run by Novartis Pharmaceuticals at 11 sites in Brazil.
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 3 inclusion and 3 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. 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?
Objective response using the RECIST criteria (time frame: 16 weeks). 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 18 Nov 2016.