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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
  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:


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):
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 November 27, 2014