Advanced Desmoid TumorPhase 2Basket 1NCT00928525
Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
A Phase 2 study testing Imatinib Mesylate in people with Advanced Desmoid Tumor and Advanced Chondrosarcoma, run by Italian Sarcoma Group at 7 sites in Italy.
Trial summary
The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Desmoid Tumor, Advanced Chondrosarcoma
- What is being tested?
- Imatinib Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 7 sitesItaly
- Study dates
- May 2007to Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of DT or CDS.
- Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ)
- Measurable or evaluable disease
- Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or metastatic disease.
- ECOG Performance status 0, 1, 2 or 3
- Adequate bone marrow, liver and renal function
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- Female patients of child-bearing potential must have negative pregnancy test.
- Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
- Written, voluntary, informed consent.
Who cannot join
- Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing
- Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ.
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
- Known brain metastasis.
- Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
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- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on target lesion.
- Major surgery within 2 weeks prior to study entry.
- Expected non-compliance to medical regimens (e.g. psychiatric diseases).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Centro di Riferimento Oncologico - Unit of Medical Oncology
Aviano, Pordenone, 33081
Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
Bologna, 40136
Policlinico S.Orsola Malpighi - Unit of Medical Oncology
Bologna, 40138
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, 10060
Istituto Nazionale Tumori - Unit of Medical Oncology
Milan, 20133
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
Roma, 00144
Ospedale Gradenigo - Unit of Medical Oncology
Torino, 10153
About this study
Official title: Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta
- Conditions
- Advanced Desmoid Tumor, Advanced Chondrosarcoma
- Being tested
- Imatinib Mesylate
- Keywords
- PDGFr alpha, PDGFr beta, KIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Mesylate | Experimental | Patients affected by Desmoid Tumor and Chondrosarcoma will receive Imatinib Mesylate 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months Receives: Drug: Imatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response will be evaluated by different imaging techniques
Measured: every three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Desmoid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Sarcoma Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928525
- Sponsor's protocol ID
- CSTI571 Basket 1
- Other IDs
- EudraCT Number: 2006-006446-33
- Acronym
- Basket 1
- Status last verified
- Dec 2018
- First submitted
- 25 Jun 2009
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
- ClinicalTrials.gov ID
- NCT00928525
- Acronym / sponsor ID
- Basket 1 / CSTI571 Basket 1
- Conditions
- Advanced Desmoid Tumor, Advanced Chondrosarcoma
- Keywords
- PDGFr alpha, PDGFr beta, KIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Italian Sarcoma GroupResearch network
- Study start
- May 2007 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Jun 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.
The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib Mesylate | Experimental | Drug: Imatinib MesylatePatients affected by Desmoid Tumor and Chondrosarcoma will receive Imatinib Mesylate 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological diagnosis of DT or CDS.
- Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ)
- Measurable or evaluable disease
- Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or metastatic disease.
- ECOG Performance status 0, 1, 2 or 3
Key exclusion criteria (10 listed)
- Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing
- Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ.
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
- Known brain metastasis.
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 Mesylate800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months | Drug | Imatinib Mesylate |
Primary outcome
Tumor response will be evaluated by different imaging techniques
Time frame: every three 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 5 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 Advanced Desmoid Tumor and Advanced Chondrosarcoma, run by Italian Sarcoma Group at 7 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 9 inclusion and 10 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 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 will be evaluated by different imaging techniques (time frame: every three 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 5 Oct 2023.