Life Threatening DiseasesPhase 2NCT00154388
Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
A Phase 2 study testing Imatinib mesylate in people with Life Threatening Diseases, run by Novartis Pharmaceuticals.
Trial summary
Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Life Threatening Diseases
- What is being tested?
- Imatinib mesylate
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Jan 2007
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≥ 15 years of age
- Life threatening disease documented by conventional criteria to be resistant to standard, approved therapy.
- Experimental documentation of functional significance of either Abl, Kit (CD117), or PDGF-R in the relevant target tissue (preferably on a sample taken within 6 weeks of study entry).
- ECOG Performance status of 0, 1, or 2.
- Adequate end organ function defined as: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN for patients with hepatic disease), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L.
- Negative serum or urine pregnancy test for women of child bearing potential (WOCBP) within 7 days of study initiation. Post menopausal women must have experienced amenorrhea for at least 12 months. Male and female patients must use effective birth control methods throughout the study and for up to 3 months after study discontinuation.
- Life expectancy of more than 3 months.
- Written, voluntary, informed consent for retrieval, evaluation and investigational use of tissue samples.
Who cannot join
- Patients who have received any other investigational agent within 28 days of study initiation.
- Patients with another primary malignancy except if other primary malignancy is neither currently clinically significant nor requiring active intervention.
- Patients with Grade III/IV cardiac problems defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study).
- Female patients who are pregnant or breast-feeding.
- Patients who have another severe and/or life threatening medical disease.
- Patients with acute or known chronic liver disease (e.g. chronic active hepatitis, cirrhosis).
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- Patients with a known diagnosis of the human immunodeficiency virus ((HIV) infection.
- Patients who have received chemotherapy within 4 weeks (6 weeks allowed for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry.
- Patients who have had major surgery within 2 weeks prior to study entry.
- Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease.
- Conditions
- Life Threatening Diseases
- Being tested
- Imatinib mesylate
- Keywords
- adenocarcinoma, leiomyosarcoma, angiosarcoma, synovial sarcoma, myelodysplastic syndrome/HES, CMML, multiple myeloma, embryonal rhabdomyosarcoma, endometrial sarcoma, adenoid cystic carcinoma, fibromatosis, ductal invasive breast carcinoma, chondrosarcoma, pleural tumor, brenner tumor, ewing sarcoma, round cell tumor, seminoma, thymic carcinoma, malignant melanoma
- Medical subject headings
- Adenocarcinoma, Leiomyosarcoma, Hemangiosarcoma, Sarcoma, Synovial, Multiple Myeloma, Rhabdomyosarcoma, Embryonal, Sarcoma, Endometrial Stromal, Carcinoma, Adenoid Cystic
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.
To examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate-sensitive tyrosine kinases
To identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease
Secondary outcomes (3)
To assess the safety and tolerability of Imatinib mesylate
To evaluate the pharmacokinetic profile of Imatinib mesylate
To assess, where feasible, the functional significance of relevant signal-transduction components in target tissues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2001
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Life Threatening DiseasesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Heinrich, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154388
- Sponsor's protocol ID
- CSTI571B2225
- Status last verified
- Nov 2016
- First submitted
- 9 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Chugh R, Wathen JK, Maki RG, Benjamin RS, Patel SR, Meyers PA, Priebat DA, Reinke DK, Thomas DG, Keohan ML, Samuels BL, Baker LH. Phase II multicenter trial of imatinib in 10 histologic subtypes of sarcoma using a bayesian hierarchical statistical model. J Clin Oncol. 2009 Jul 1;27(19):3148-53. doi: 10.1200/JCO.2008.20.5054. Epub 2009 May 18.
PubMed 19451433
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 II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
- ClinicalTrials.gov ID
- NCT00154388
- Acronym / sponsor ID
- CSTI571B2225
- Conditions
- Life Threatening Diseases
- Keywords
- adenocarcinoma, leiomyosarcoma, angiosarcoma, synovial sarcoma, myelodysplastic syndrome/HES, CMML, multiple myeloma, embryonal rhabdomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 12 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.
Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 15 years of age
- Life threatening disease documented by conventional criteria to be resistant to standard, approved therapy.
- Experimental documentation of functional significance of either Abl, Kit (CD117), or PDGF-R in the relevant target tissue (preferably on a sample taken within 6 weeks of study entry).
- ECOG Performance status of 0, 1, or 2.
- Adequate end organ function defined as: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN for patients with hepatic disease), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L.
Key exclusion criteria (11 listed)
- Patients who have received any other investigational agent within 28 days of study initiation.
- Patients with another primary malignancy except if other primary malignancy is neither currently clinically significant nor requiring active intervention.
- Patients with Grade III/IV cardiac problems defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study).
- Female patients who are pregnant or breast-feeding.
- Patients who have another severe and/or life threatening 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 mesylate | Drug | – |
Primary outcome
To examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate-sensitive tyrosine kinases
To identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease
3 secondary outcomes
To assess the safety and tolerability of Imatinib mesylate
To evaluate the pharmacokinetic profile of Imatinib mesylate
To assess, where feasible, the functional significance of relevant signal-transduction components in target tissues
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.
- Results publication: PubMed 19451433Chugh R, Wathen JK, Maki RG, Benjamin RS, Patel SR, Meyers PA, Priebat DA, Reinke DK, Thomas DG, Keohan ML, Samuels BL, Baker LH. Phase II multicenter trial of imatinib in 10 histologic subtypes of sarcoma using a bayesian hierarchical statistical model. J Clin Oncol. 2009 Jul 1;27(19):3148-53. doi: 10.1200/JCO.2008.20.5054. Epub 2009 May 18.
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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.
Michael Heinrich, MD principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib mesylate in people with Life Threatening Diseases, run by Novartis Pharmaceuticals.
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 8 inclusion and 11 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.
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?
To examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate-sensitive tyrosine kinases. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00154388, which also lists 1 linked publication.
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.