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TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Phase 1
Terminated
Conditions
Multiple Myeloma
Registration Number
NCT00243763
Lead Sponsor
Novartis
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
64
Inclusion Criteria
  • Confirmed diagnosis of multiple myeloma
  • Evidence of relapsed or refractory disease
Read More
Exclusion Criteria
  • Intracranial disease or epidural disease
  • Clinically significant cardiac disease
  • Diabetes mellitus
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Maximum tolerated dose
Dose limiting toxicity
Safety profile
Secondary Outcome Measures
NameTimeMethod
Evaluation of pharmacokinetics and pharmacodynamics

Trial Locations

Locations (5)

Emory University

🇺🇸

Atlanta, Georgia, United States

Mayo Clinic - Arizona

🇺🇸

Scottsdale, Arizona, United States

Dana-Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Mayo Clinic - Minnesota

🇺🇸

Rochester, Minnesota, United States

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