Malignant Peripheral Nerve Sheath TumorsPhase 2/3NCT00427583
Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
A Phase 2/3 study testing imatinib mesylate in people with Malignant Peripheral Nerve Sheath Tumors, run by Novartis Pharmaceuticals at 2 sites in Germany.
Trial summary
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Peripheral Nerve Sheath Tumors
- What is being tested?
- imatinib mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesGermany
- Study dates
- May 2006to Apr 2009
- Phase
- Phase 2/3
- 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 malignant MPNST
- Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months.
Who cannot join
- Patient has received any other investigational agents within 28 days of first day of study drug dosing.
- Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry.
- Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control.
- Known CNS metastases
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Hamburg
About this study
Official title: An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors
- Conditions
- Malignant Peripheral Nerve Sheath Tumors
- Being tested
- imatinib mesylate
- Keywords
- Malignant,, peripheral,, nerve sheath tumors,, MPNST,, neurofibromatosis,, NF1,, Imatinib mesylate
- Medical subject headings
- Neurofibrosarcoma, Nerve Sheath Neoplasms, Neurofibromatoses
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 |
|---|---|---|
| STI571 | Experimental | Not described Receives: Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.
Measured: Every 36 weeks
Secondary outcomes (3)
Time to progression assessed by an MRI scan.
Measured: Every 36 weeks
Overall survival
Measured: Every 36 weeks
Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs
Measured: Every 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startMay 2006
- Primary completionApr 2009
Why it stopped: stopped due to slow recruitment and no effect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Peripheral Nerve Sheath 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427583
- Sponsor's protocol ID
- CSTI571BDE57
- Status last verified
- Aug 2012
- First submitted
- 25 Jan 2007
- Last updated
- 7 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
- ClinicalTrials.gov ID
- NCT00427583
- Acronym / sponsor ID
- CSTI571BDE57
- Conditions
- Malignant Peripheral Nerve Sheath Tumors
- Keywords
- Malignant,, peripheral,, nerve sheath tumors,, MPNST,, neurofibromatosis,, NF1,, Imatinib mesylate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stopped due to slow recruitment and no effect
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2009 (actual)
- First posted
- 29 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.
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STI571 | Experimental | Drug: imatinib mesylate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥18 years of age
- Histologically documented diagnosis of malignant MPNST
- Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months.
Key exclusion criteria (5 listed)
- Patient has received any other investigational agents within 28 days of first day of study drug dosing.
- Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry.
- Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control.
- Known CNS metastases
- 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 | STI571 |
Primary outcome
Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.
Time frame: Every 36 weeks
3 secondary outcomes
Time to progression assessed by an MRI scan.
Time frame: Every 36 weeks
Overall survival
Time frame: Every 36 weeks
Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs
Time frame: Every 36 weeks
Results and safety
The study was stopped early (reason given: stopped due to slow recruitment and no effect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing imatinib mesylate in people with Malignant Peripheral Nerve Sheath Tumors, run by Novartis Pharmaceuticals at 2 sites in Germany.
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 5 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 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: stopped due to slow recruitment and no effect). 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?
Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. (time frame: Every 36 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 7 Aug 2012.