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TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00243763
Recruitment Status : Terminated
First Posted : October 25, 2005
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Novartis

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: TKI258 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maximum tolerated dose
  2. Dose limiting toxicity
  3. Safety profile

Secondary Outcome Measures :
  1. Evaluation of pharmacokinetics and pharmacodynamics

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

ClinicalTrials.gov Identifier: NCT00243763     History of Changes
Other Study ID Numbers: CTKI258A2103
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

Keywords provided by Novartis:
Refractory Multiple Myeloma or
Relapsed Multiple Myeloma

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