TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

NCT ID: NCT00243763

Last Updated: 2009-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Multiple Myeloma

Keywords

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Refractory Multiple Myeloma or Relapsed Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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TKI258

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Mayo Clinic - Arizona

Scottsdale, Arizona, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Mayo Clinic - Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23400739 (View on PubMed)

Other Identifiers

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CTKI258A2103

Identifier Type: -

Identifier Source: org_study_id