Refractory Desmoplastic Small Round Cell TumorsPhase 1/2NCT00417807
Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors
A Phase 1/2 study testing Imatinib mesilate in people with Refractory Desmoplastic Small Round Cell Tumors, run by Novartis Pharmaceuticals at 8 sites in Italy.
Trial summary
An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Refractory Desmoplastic Small Round Cell Tumors
- What is being tested?
- Imatinib mesilate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 8 sitesItaly
- Study dates
- Aug 2005to Jun 2009
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients > 16 years of age.
- Histologically documented diagnosis of DSRCT, unresponsive or in no complete remission after any conventional multimodality approach.
- Immunohistochemical documentation of activated PDGF-R expression by tumor
- At least one measurable site of disease
- Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group)
- Adequate end organ function
Who cannot join
- Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- Patient is < 5 years free of another primary malignancy
- Patient with congestive heart failure or myocardial infarction within 6 months of study
- Female patients who are pregnant or breast-feeding.
- Severe and/or uncontrolled medical disease
- Known brain metastasis.
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- Chronic active hepatitis or cirrhosis
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
- Previous radiotherapy to > 25 % of the bone marrow
- Major surgery within 2 weeks prior to study entry.
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Novartis Investigative Site
Ivrea
Novartis Investigative Site
Milan
Novartis Investigative Site
Naples
Novartis Investigative Site
Padova
Novartis Investigative Site
Ravenna
Novartis Investigative Site
Rozzano
Novartis Investigative Site
Torino
Novartis Investigative Stie
Vatania
About this study
Official title: Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R
An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria
- Being tested
- Imatinib mesilate
- Keywords
- refractory desmoplastic small round cell tumors, PDGF-R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib mesilateDrug
Also called STI571
| Study group | Role | What they receive |
|---|---|---|
| Gleevec/Glivec | Experimental | Not described Receives: Drug: Imatinib mesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tumor response rates
An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.
Measured: Assessed every 3 months
Secondary outcomes (4)
Explore how Imatinib cooperated with other treatment modatilities
Recorded survival after treatment and other associated treatment modalities.
Measured: Survival data was collected until death
Safety and tolerability
Measured: Safety data collected until patients were no longer in study
Conversion rate to surgical resectability
Assessed actual resectability rate after therapy compared to resectability before therapy.
Measured: After best tumor response.
Mutational analysis of molecular targets of imatinib (at any time during the study)
Measured: At any time during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startAug 2005
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Desmoplastic Small Round Cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417807
- Sponsor's protocol ID
- CSTI571BIT06
- Status last verified
- Dec 2010
- First submitted
- 2 Jan 2007
- Last updated
- 24 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R
- ClinicalTrials.gov ID
- NCT00417807
- Acronym / sponsor ID
- CSTI571BIT06
- Keywords
- refractory desmoplastic small round cell tumors, PDGF-R
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jun 2009 (actual)
- First posted
- 4 Jan 2007 (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.
An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gleevec/Glivec | Experimental | Drug: Imatinib mesilate |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients > 16 years of age.
- Histologically documented diagnosis of DSRCT, unresponsive or in no complete remission after any conventional multimodality approach.
- Immunohistochemical documentation of activated PDGF-R expression by tumor
- At least one measurable site of disease
- Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group)
Key exclusion criteria (12 listed)
- Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- Patient is < 5 years free of another primary malignancy
- Patient with congestive heart failure or myocardial infarction within 6 months of study
- Female patients who are pregnant or 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 mesilateAlso: STI571 | Drug | Gleevec/Glivec |
Primary outcome
Overall tumor response rates
Time frame: Assessed every 3 months
An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.
4 secondary outcomes
Explore how Imatinib cooperated with other treatment modatilities
Time frame: Survival data was collected until death
Safety and tolerability
Time frame: Safety data collected until patients were no longer in study
Conversion rate to surgical resectability
Time frame: After best tumor response.
Mutational analysis of molecular targets of imatinib (at any time during the study)
Time frame: At any time during the study
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 24 Dec 2010.
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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 Pharmeceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Imatinib mesilate in people with Refractory Desmoplastic Small Round Cell Tumors, run by Novartis Pharmaceuticals at 8 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 6 inclusion and 12 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 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Overall tumor response rates (time frame: Assessed 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 24 Dec 2010.