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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
Not Enrolling
Both
Multiple Myeloma

Thank you

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 InstituteTampa, Florida  33612
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Emory UniversityAtlanta, Georgia  30322
Mayo Clinic - ArizonaScottsdale, Arizona  85259
Mayo Clinic - MinnesotaRochester, Minnesota  55905