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

NCT01028222 | Completed Phase 2 Results

• 2 other identifiers: CAMN107B23012009-015514-21
• Study Type: interventional
• Target: 55
• Locations: 14 countries
• Sites: 49

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.

Conditions

Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  End of study (up to 39 months)

Secondary Outcomes (7)

• Durable Overall Response Rate (DORR)

  End of study (up to 39 months)

• Progression Free Survival (PFS)

  End of study (up to 39 months)

• Overall Survival (OS)

  End of study (up to 39 months)

• Time to Objective Response (TOR)

  End of study (up to 39 months)

• Disease Control Rate (DCR)

  End of study (up to 39 months)

Study Arms (2)

Nilotinib

EXPERIMENTAL

400 mg twice daily

Drug: Nilotinib

DTIC

ACTIVE COMPARATOR

850 mg/m2 IV every 3 weeks

Drug: DTIC

Interventions

Nilotinib DRUG

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

Also known as: AMN107

Nilotinib

DTIC DRUG

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

Also known as: Dacarbazine

DTIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• Patients with c-Kit amplifications only and no mutation
• Patients with any history of brain metastases
• Patients who have had any prior treatment with TKIs
• Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit
• Acute or chronic liver or renal disease considered unrelated to melanoma

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (49)

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

Duarte, California, 91010-3000, United States

Location

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

La Jolla, California, 92093-0658, United States

Location

University of California at Los Angeles UCLA

Los Angeles, California, 90024, United States

Location

California Pacific Medical Center California Pacific Med

San Francisco, California, 94120-7999, United States

Location

University of Colorado Univ Colorado 2

Aurora, Colorado, 80045, United States

Location

Rush University Medical Center SC

Chicago, Illinois, 60612, United States

Location

Oncology Specialists, SC Dept.of Oncology Specialists

Park Ridge, Illinois, 60068-0736, United States

Location

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

Baltimore, Maryland, 21231, United States

Location

Dana Farber Cancer Institute DFCI - Brookline

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic - Rochester Mayo Clinic- Gonda

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine CAMN107B2301

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Case Western Reserve Case Western

Cleveland, Ohio, 44106-5000, United States

Location

Baylor Health Care System/Sammons Cancer Center Baylor 2

Dallas, Texas, 75246, United States

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1125ABE, Argentina

Location

Novartis Investigative Site

North Sydney, New South Wales, 2060, Australia

Location

Novartis Investigative Site

Adelaide, South Australia, 5000, Australia

Location

Novartis Investigative Site

East Melbourne, Victoria, 3002, Australia

Location

Novartis Investigative Site

Heidelberg, Victoria, 3084, Australia

Location

Novartis Investigative Site

Brussels, 1090, Belgium

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30150-281, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01246-000, Brazil

Location

Novartis Investigative Site

Toronto, Ontario, M4N 3M5, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 1Z5, Canada

Location

Novartis Investigative Site

Beijing, 100036, China

Location

Novartis Investigative Site

Cologne, 50937, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Padua, PD, 35100, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Amsterdam, 1081 HV, Netherlands

Location

Novartis Investigative Site

Nijmegen, 6525 GA, Netherlands

Location

Novartis Investigative Site

Singapore, Singapore, 169610, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Gothenburg, SE-413 45, Sweden

Location

Novartis Investigative Site

Malmo, SE-205 02, Sweden

Location

Novartis Investigative Site

Stockholm, SE-171 76, Sweden

Location

Novartis Investigative Site

Uppsala, SE-751 85, Sweden

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28327988 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Melanoma

Interventions

nilotinib; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Novartis
• Organization: Study Director

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2015
• Results First Posted: November 26, 2015

Record last verified: 2015-11

Locations

SE (4); BE (3); AR (1); CA (2); DE (5); AU (4); IT (6); BR (3); US (14); NL (2); CN (1); ES (2); CH (1); SG (1)