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

Study Timeline

• Study First Submitted: 2005-10-21
• Study First Submitted QC: 2005-10-21
• Study First Posted: 2005-10-25
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-20
• Last Update Posted: 2009-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose
Dose limiting toxicity
Safety profile

Secondary Outcome Measures

Name	Time	Method
Evaluation of pharmacokinetics and pharmacodynamics

Trial Locations

Locations (5)

Mayo Clinic - Arizona; 🇺🇸 Scottsdale, Arizona, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic - Minnesota; 🇺🇸 Rochester, Minnesota, United States