Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 2:38 AM
Study NCT ID:
NCT00303251
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2006-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of TKI258 in Advanced/Metastatic Melanoma Subjects
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: