MedDataX Logo

A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

NCT ID: NCT01028222

Last Updated: 2015-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This trial began as a multi-center, randomized, Phase III, controlled trial for nilotinib vs (DTIC) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-Kit mutated metastatic and/or inoperable melanoma. The study was open to patients with mucosal or acral melanoma.

Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study with protocol Amendment 2 (27-Jul-2011). While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to dacarbazine ( DTIC ) DTIC were not). Patients randomized to DTIC were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Melanoma AMN107 c-Kit c-Kit mutated metastatic and/or inoperable melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nilotinib

400 mg twice daily

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Nilotinib was provided as 200 mg hard gelatin capsules for oral use.

DTIC

850 mg/m2 IV every 3 weeks

Group Type ACTIVE_COMPARATOR

DTIC

Intervention Type DRUG

DTIC was supplied locally as sterile powder for i.v. infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nilotinib

Nilotinib was provided as 200 mg hard gelatin capsules for oral use.

Intervention Type DRUG

DTIC

DTIC was supplied locally as sterile powder for i.v. infusion.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AMN107 Dacarbazine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City of Hope National Medical Center City of Hope national Med Ctr

Duarte, California, United States

Site Status

University of California San Diego - Moores Cancer Center UCSD Moores Cancer Center

La Jolla, California, United States

Site Status

University of California at Los Angeles UCLA

Los Angeles, California, United States

Site Status

California Pacific Medical Center California Pacific Med

San Francisco, California, United States

Site Status

University of Colorado Univ Colorado 2

Aurora, Colorado, United States

Site Status

Rush University Medical Center SC

Chicago, Illinois, United States

Site Status

Oncology Specialists, SC Dept.of Oncology Specialists

Park Ridge, Illinois, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Medical Oncology

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute DFCI - Brookline

Boston, Massachusetts, United States

Site Status

Mayo Clinic - Rochester Mayo Clinic- Gonda

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine CAMN107B2301

St Louis, Missouri, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Case Western Reserve Case Western

Cleveland, Ohio, United States

Site Status

Baylor Health Care System/Sammons Cancer Center Baylor 2

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

North Sydney, New South Wales, Australia

Site Status

Novartis Investigative Site

Adelaide, South Australia, Australia

Site Status

Novartis Investigative Site

East Melbourne, Victoria, Australia

Site Status

Novartis Investigative Site

Heidelberg, Victoria, Australia

Site Status

Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Site Status

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Erlangen, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Novartis Investigative Site

Meldola, FC, Italy

Site Status

Novartis Investigative Site

Genova, GE, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Padua, PD, Italy

Site Status

Novartis Investigative Site

Siena, SI, Italy

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Nijmegen, , Netherlands

Site Status

Novartis Investigative Site

Singapore, Singapore, Singapore

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Novartis Investigative Site

Gothenburg, , Sweden

Site Status

Novartis Investigative Site

Malmo, , Sweden

Site Status

Novartis Investigative Site

Stockholm, , Sweden

Site Status

Novartis Investigative Site

Uppsala, , Sweden

Site Status

Novartis Investigative Site

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland Thailand United States Argentina Australia Belgium Brazil Canada China Germany Italy Netherlands Singapore Spain Sweden Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28327988 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://NovartisClinicalTrials.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-015514-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAMN107B2301

Identifier Type: -

Identifier Source: org_study_id