Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Principal Investigator
Novartis
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis
Authority:
United States: Food and Drug Administration
Study ID:
CTKI258A2103
NCT ID:
NCT00243763
Start Date:
Completion Date:
Related Keywords:
- Multiple Myeloma
- Refractory Multiple Myeloma or
- Relapsed Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Emory University | Atlanta, Georgia 30322 |
| Mayo Clinic - Arizona | Scottsdale, Arizona 85259 |
| Mayo Clinic - Minnesota | Rochester, Minnesota 55905 |
