NCT00243763

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

First QC Date

October 21, 2005

Last Update Submit

November 20, 2009

Conditions

Multiple Myeloma

Keywords

Refractory Multiple Myeloma orRelapsed Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose

  • Dose limiting toxicity

  • Safety profile

Secondary Outcomes (1)

  • Evaluation of pharmacokinetics and pharmacodynamics

Interventions

TKI258DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of multiple myeloma
  • Evidence of relapsed or refractory disease

You may not qualify if:

  • Intracranial disease or epidural disease
  • Clinically significant cardiac disease
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mayo Clinic - Arizona

Scottsdale, Arizona, 85259, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic - Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 23400739DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 25, 2005

Last Updated

November 23, 2009

Record last verified: 2009-11

Locations

US(5)