GlioblastomaPhase 2NCT00171938
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
A Phase 2 study testing imatinib mesylate in people with Glioblastoma, run by Novartis at 1 site in Brazil.
Trial summary
This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for up to 12 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- imatinib mesylate
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2004to Jun 2006
- 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
- Histologically documented diagnosis of GBM.
- Immunohistochemical documentation of expression of PDGFR.
- Unresectable, recurrent disease by MRI and spectroscopy
Who cannot join
- Treatment with any other investigational agents within 28 days of first day of study drug dosing.
- Concurrent chemotherapy.
- Concurrent radiotherapy.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for up to 12 months
- Conditions
- Glioblastoma
- Being tested
- imatinib mesylate
- Keywords
- Glioblastoma, Brain tumors, Imatinib, PDGFR
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Secondary outcomes (2)
Objective Tumoral Response defined by RECISt criteria performed by MRI
OS (overall survival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171938
- Sponsor's protocol ID
- CSTI571BBR03
- Status last verified
- Nov 2009
- First submitted
- 13 Sep 2005
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
- ClinicalTrials.gov ID
- NCT00171938
- Acronym / sponsor ID
- CSTI571BBR03
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Brain tumors, Imatinib, PDGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2004 (actual)
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 15 Sep 2005 (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 is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for up to 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (3 listed)
- Histologically documented diagnosis of GBM.
- Immunohistochemical documentation of expression of PDGFR.
- Unresectable, recurrent disease by MRI and spectroscopy
Key exclusion criteria (4 listed)
- Treatment with any other investigational agents within 28 days of first day of study drug dosing.
- Concurrent chemotherapy.
- Concurrent radiotherapy.
- Other protocol-defined 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 | – |
Primary outcome
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
2 secondary outcomes
Objective Tumoral Response defined by RECISt criteria performed by MRI
OS (overall survival)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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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 study chair
Novartis
1 site 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 Glioblastoma, run by Novartis at 1 site 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 4 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: stopped early, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early. Results are not available in the source record.
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?
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 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 24 Feb 2017.