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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01028222
Registration number
NCT01028222
Ethics application status
Date submitted
7/12/2009
Date registered
9/12/2009
Date last updated
30/12/2015
Titles & IDs
Public title
A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation
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Scientific title
The TEAM Trial (Tasigna Efficacy in Advanced Melanoma): A Phase II, Open Label, Multi-center, Single-arm Study to Assess the Efficacy of Tasigna ® in the Treatment of Patients With Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation
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Secondary ID [1]
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2009-015514-21
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Secondary ID [2]
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CAMN107B2301
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Universal Trial Number (UTN)
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Trial acronym
TEAM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nilotinib
Treatment: Drugs - DTIC
Experimental: Nilotinib - 400 mg twice daily
Active Comparator: DTIC - 850 mg/m2 IV every 3 weeks
Treatment: Drugs: Nilotinib
Nilotinib was provided as 200 mg hard gelatin capsules for oral use.
Treatment: Drugs: DTIC
DTIC was supplied locally as sterile powder for i.v. infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.
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Timepoint [1]
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End of study (up to 39 months)
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Secondary outcome [1]
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Durable Overall Response Rate (DORR)
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Assessment method [1]
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DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.
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Timepoint [1]
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End of study (up to 39 months)
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Secondary outcome [2]
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Progression Free Survival (PFS)
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Assessment method [2]
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PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.
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Timepoint [2]
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End of study (up to 39 months)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS was defined as the time from the date of the start of treatment to the date of death due to any cause.
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Timepoint [3]
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End of study (up to 39 months)
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Secondary outcome [4]
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Time to Objective Response (TOR)
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Assessment method [4]
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TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.
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Timepoint [4]
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End of study (up to 39 months)
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.
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Timepoint [5]
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End of study (up to 39 months)
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Secondary outcome [6]
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PFS Rate
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Assessment method [6]
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PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.
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Timepoint [6]
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End of study (up to 39 months)
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Secondary outcome [7]
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OS Rate
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Assessment method [7]
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OS was defined as the time from the date of the start of treatment to the date of death due to any cause.
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Timepoint [7]
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End of study (up to 39 months)
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Eligibility
Key inclusion criteria
1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11
or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the
central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or
more measurable lesions as detected by radiological or photographic methods and assessed
according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter
(using a slice thickness of 5 mm)or double the slice thickness to be considered a target
lesion. Target lesions should not be selected in previously irradiated fields unless there
is clear evidence of progression 5. WHO performance status 0 - 2
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon
not allowed by the inclusion criteria
2. Patients with c-Kit amplifications only and no mutation
3. Patients with any history of brain metastases
4. Patients who have had any prior treatment with TKIs
5. Patients receiving medications or herbal extracts which interfere with nilotinib
metabolism which are not discontinued by the time of the baseline visit
6. Acute or chronic liver or renal disease considered unrelated to melanoma
Other protocol-defined inclusion/exclusion criteria may have applied.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - North Sydney
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Recruitment hospital [2]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [3]
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Novartis Investigative Site - East Melbourne
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Recruitment hospital [4]
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Novartis Investigative Site - Heidelberg
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Illinois
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Maryland
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Massachusetts
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Minnesota
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Missouri
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Belgium
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Bruxelles
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Belgium
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Leuven
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MG
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Brazil
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Brazil
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Ontario
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Essen
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Germany
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Köln
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Germany
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Tübingen
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FC
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GE
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Italy
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Spain
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Cataluña
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Uppsala
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Zürich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether nilotinib is efficacious in the treatment
of metastatic and/or inoperable melanoma harboring a c-Kit mutation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01028222
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01028222
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