Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Safety of TKI258 in Advanced/Metastatic Melanoma Subjects
This study is currently recruiting participants.
Verified by Novartis, June 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00303251
  Purpose

This study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TKI258. Pharmacokinetics and pharmacodynamics will be performed on all subjects. The eligible subject population consists of subjects who have been diagnosed with locally advanced or metastatic melanoma that is refractory to standard therapy or for which no curative standard therapy exists.


Condition Intervention Phase
Melanoma
Drug: TKI258
Phase I
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Chir 258
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TKI258 (CHIR-258) in Patients With Locally Advanced or Metastatic Melanoma

Further study details as provided by Novartis:

Primary Outcome Measures:
  • • Maximum tolerated dose • Dose limiting toxicity • Plasma and whole blood pharmacokinetics • Tumor response

Secondary Outcome Measures:
  • • Safety profile • Effect of TKI258 on biomarkers in the blood and tumor tissue • Assess the pharmacokinetic and pharmacodynamic relationship

Estimated Enrollment: 64
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.
  • Measurable disease
  • Must be eighteen years of age or older
  • Must meet baseline laboratory requirements
  • ECOG performance status 0 or 1
  • Adults of reproductive potential must agree to use effective contraception or be sterile

Exclusion Criteria:

  • Concurrent therapy with any other investigational agent
  • Uncontrolled central nervous system metastases
  • Impaired cardiac function or clinically significant cardiac disease
  • Received

    • chemotherapy, targeted therapy or monoclonal antibody therapy ≤4 weeks
    • biological therapy or immunotherapy (therapeutic or diagnostic) ≤2 weeks
    • an investigational agent (therapeutic or diagnostic) ≤4 weeks prior to starting study drug or has not recovered from side effects of such therapy
  • Received any hematopoietic colony-stimulating factor (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin is allowed.
  • Has undergone major surgery ≤ 2 weeks prior to starting study drug or has not recovered from side effects of such surgery.
  • Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea, diarrhea, vomiting
  • Pregnant or breast feeding women
  • History of another primary malignancy that is currently clinically significant or currently requires active intervention.
  • Chronic anticoagulation therapy with full strength aspirin, Coumadin, or heparin.
  • History of thromboembolic or cerebrovascular events within the last 12 months.
  • History of rectal bleeding, bloody vomit, or spitting up blood within the last 3 months.
  • Known diagnosis of HIV infection (HIV testing is not mandatory)
  • Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort and quinidine is prohibited.
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the patient inappropriate for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303251

Contacts
Contact: Novartis 1 800 340 6843

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Beverly Taft     502-562-3429     bstaft01@gwise.louisville.edu    
Principal Investigator: Jason Chesney, M.D            
United States, Pennsylvania
University of Pittsburgh Cancer Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Mary Rae     412-647-8569     raemm@upmc.edu    
Principal Investigator: John Kirkwood, M.D            
United States, Texas
MD Anderson Cancer Recruiting
Houston, Texas, United States, 77030
Contact: Suzanne Cain     713-792-8874     scain@mdanderson.org    
Principal Investigator: Kevin Kim, M.D.            
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CTKI258A2105
Study First Received: March 14, 2006
Last Updated: June 26, 2008
ClinicalTrials.gov Identifier: NCT00303251  
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Locally Advanced or Metastatic Melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009