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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
2009-015514-21
Secondary ID [2] 0 0
CAMN107B2301
Universal Trial Number (UTN)
Trial acronym
TEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) - 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.
Timepoint [1] 0 0
End of study (up to 39 months)
Secondary outcome [1] 0 0
Durable Overall Response Rate (DORR) - 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.
Timepoint [1] 0 0
End of study (up to 39 months)
Secondary outcome [2] 0 0
Progression Free Survival (PFS) - 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.
Timepoint [2] 0 0
End of study (up to 39 months)
Secondary outcome [3] 0 0
Overall Survival (OS) - OS was defined as the time from the date of the start of treatment to the date of death due to any cause.
Timepoint [3] 0 0
End of study (up to 39 months)
Secondary outcome [4] 0 0
Time to Objective Response (TOR) - 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.
Timepoint [4] 0 0
End of study (up to 39 months)
Secondary outcome [5] 0 0
Disease Control Rate (DCR) - 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.
Timepoint [5] 0 0
End of study (up to 39 months)
Secondary outcome [6] 0 0
PFS Rate - 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.
Timepoint [6] 0 0
End of study (up to 39 months)
Secondary outcome [7] 0 0
OS Rate - OS was defined as the time from the date of the start of treatment to the date of death due to any cause.
Timepoint [7] 0 0
End of study (up to 39 months)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - North Sydney
Recruitment hospital [2] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [4] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussel
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Brazil
State/province [15] 0 0
MG
Country [16] 0 0
Brazil
State/province [16] 0 0
RJ
Country [17] 0 0
Brazil
State/province [17] 0 0
SP
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
China
State/province [19] 0 0
Beijing
Country [20] 0 0
Germany
State/province [20] 0 0
Erlangen
Country [21] 0 0
Germany
State/province [21] 0 0
Essen
Country [22] 0 0
Germany
State/province [22] 0 0
Köln
Country [23] 0 0
Germany
State/province [23] 0 0
Muenchen
Country [24] 0 0
Germany
State/province [24] 0 0
Tübingen
Country [25] 0 0
Italy
State/province [25] 0 0
FC
Country [26] 0 0
Italy
State/province [26] 0 0
GE
Country [27] 0 0
Italy
State/province [27] 0 0
MI
Country [28] 0 0
Italy
State/province [28] 0 0
PD
Country [29] 0 0
Italy
State/province [29] 0 0
SI
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nijmegen
Country [32] 0 0
Singapore
State/province [32] 0 0
Singapore
Country [33] 0 0
Spain
State/province [33] 0 0
Catalunya
Country [34] 0 0
Spain
State/province [34] 0 0
Cataluña
Country [35] 0 0
Sweden
State/province [35] 0 0
Goteborg
Country [36] 0 0
Sweden
State/province [36] 0 0
Malmö
Country [37] 0 0
Sweden
State/province [37] 0 0
Stockholm
Country [38] 0 0
Sweden
State/province [38] 0 0
Uppsala
Country [39] 0 0
Switzerland
State/province [39] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01028222
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications