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

History of Changes

Purpose

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).

Condition	Intervention	Phase
Multiple Myeloma	Drug: TKI258	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Maximum tolerated dose
Dose limiting toxicity
Safety profile

Secondary Outcome Measures:

Evaluation of pharmacokinetics and pharmacodynamics


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 multiple myeloma
Evidence of relapsed or refractory disease

Exclusion Criteria:

Intracranial disease or epidural disease
Clinically significant cardiac disease
Diabetes mellitus

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243763

Locations


United States, Arizona
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic - Minnesota
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00243763 History of Changes
Other Study ID Numbers:	CTKI258A2103
Study First Received:	October 21, 2005
Last Updated:	November 20, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:


Refractory Multiple Myeloma or Relapsed Multiple Myeloma

Additional relevant MeSH terms:


Multiple Myeloma Neoplasms, Plasma Cell Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders	Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Paraproteinemias Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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