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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Timepoint [1] 0 0
End of study (up to 39 months)
Secondary outcome [1] 0 0
Durable Overall Response Rate (DORR)
Timepoint [1] 0 0
End of study (up to 39 months)
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
End of study (up to 39 months)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
End of study (up to 39 months)
Secondary outcome [4] 0 0
Time to Objective Response (TOR)
Timepoint [4] 0 0
End of study (up to 39 months)
Secondary outcome [5] 0 0
Disease Control Rate (DCR)
Timepoint [5] 0 0
End of study (up to 39 months)
Secondary outcome [6] 0 0
PFS Rate
Timepoint [6] 0 0
End of study (up to 39 months)
Secondary outcome [7] 0 0
OS Rate
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
Sex
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
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
55
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
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United States of America
State/province [2] 0 0
Colorado
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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/study/NCT01028222
Trial related presentations / publications
Guo J, Carvajal RD, Dummer R, Hauschild A, Daud A, Bastian BC, Markovic SN, Queirolo P, Arance A, Berking C, Camargo V, Herchenhorn D, Petrella TM, Schadendorf D, Sharfman W, Testori A, Novick S, Hertle S, Nourry C, Chen Q, Hodi FS. Efficacy and safety of nilotinib in patients with KIT-mutated metastatic or inoperable melanoma: final results from the global, single-arm, phase II TEAM trial. Ann Oncol. 2017 Jun 1;28(6):1380-1387. doi: 10.1093/annonc/mdx079.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01028222