Back to resultsTKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TKI258
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Refractory Multiple Myeloma or, Relapsed Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic - Arizona
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University
- Dana-Farber Cancer Institute
- Mayo Clinic - Minnesota
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Dose limiting toxicity
Safety profile
Secondary Outcome Measures
Evaluation of pharmacokinetics and pharmacodynamics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00243763
Brief Title
TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
Official Title
Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Refractory Multiple Myeloma or, Relapsed Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TKI258
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Title
Dose limiting toxicity
Title
Safety profile
Secondary Outcome Measure Information:
Title
Evaluation of pharmacokinetics and pharmacodynamics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic - Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic - Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23400739
Citation
Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.
Results Reference
derived
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TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
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