TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00243763
First received: October 21, 2005
Last updated: November 20, 2009
Last verified: November 2009

October 21, 2005
November 20, 2009
Not Provided
Not Provided
  • Maximum tolerated dose
  • Dose limiting toxicity
  • Safety profile
Not Provided
Complete list of historical versions of study NCT00243763 on ClinicalTrials.gov Archive Site
Evaluation of pharmacokinetics and pharmacodynamics
Not Provided
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TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

The primary objective of this study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with refractory or relapsed multiple myeloma (MM).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: TKI258
Not Provided
Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
Not Provided
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Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma
  • Evidence of relapsed or refractory disease

Exclusion Criteria:

  • Intracranial disease or epidural disease
  • Clinically significant cardiac disease
  • Diabetes mellitus
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00243763
CTKI258A2103
Not Provided
Not Provided
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP