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NCT00243763 Clinical Trial

TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00243763
Other study ID # CTKI258A2103
Secondary ID
Status Terminated
Phase Phase 1
First received October 21, 2005
Last updated November 20, 2009

Study information
Verified date November 2009
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 64
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• TKI258

Locations
Country Name City State
United States Emory University Atlanta Georgia
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Mayo Clinic - Minnesota Rochester Minnesota
United States Mayo Clinic - Arizona Scottsdale Arizona
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose
Primary Dose limiting toxicity
Primary Safety profile
Secondary Evaluation of pharmacokinetics and pharmacodynamics
See also
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Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1