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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: TKI258 | Phase 1 |
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 |

- Maximum tolerated dose
- Dose limiting toxicity
- Safety profile
- Evaluation of pharmacokinetics and pharmacodynamics

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Chair: | Novartis | Novartis |
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 |