TKI258 in Subjects With Refractory or Relapsed Multiple M... | NCT00243763

Studies
TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

NCT00243763

Sponsor

Novartis

Status

Terminated

Last Update Posted

Nov 23, 2009Estimated

Enrollment

64Estimated

Phase

Phase 1

Conditions

Multiple Myeloma

Interventions

TKI258

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 21, 2005

First Submission Date that Met QC Criteria

Oct 21, 2005

First Posted Date

Oct 25, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2009

Last Update Posted Date

Nov 23, 2009Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Name	Type	Description	Arm Group Labels	Other Names
TKI258	Drug

Measure	Description	Time Frame
Evaluation of pharmacokinetics and pharmacodynamics

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis	Novartis	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic - Arizona		Scottsdale	Arizona	85259	United States
H. Lee Moffitt Cancer Center and Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23400739	Derived	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.

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders