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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00303251 |
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 |
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Melanoma |
Drug: TKI258 |
Phase I Phase II |
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 |
Estimated Enrollment: | 64 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Received
Contact: Novartis | 1 800 340 6843 |
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. |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CTKI258A2105 |
Study First Received: | March 14, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00303251 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Locally Advanced or Metastatic Melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |