A Study of LY2523355 in Patients With Solid Cancer | NCT01358019

Studies
A Study of LY2523355 in Patients With Solid Cancer

NCT01358019

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Jan 28, 2013Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Solid Tumors

Interventions

LY2523355

Countries

Japan

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

May 19, 2011

First Posted Date

May 23, 2011Estimated

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

Jan 25, 2013

Last Update Posted Date

Jan 28, 2013Estimated

Description Module

Brief Summary

The primary objective of this study is to examine a recommended dose for subsequent phase trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients with advanced and/or metastatic cancer. The secondary objectives are to study the pharmacokinetics and antitumor effect.

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY2523355	Experimental		Drug: LY2523355

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY2523355	Drug	Days 1, 2, and 3 in a cycle that consists of 21-days	LY2523355

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0
Number of patients with adverse events

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics	Plasma concentration of LY2523355 and metabolite
Antitumor effect	Response evaluation criteria in solid tumors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological and/or cytological evidence of solid tumors
A diagnosis of advanced and/or metastatic solid tumors
Patients who are refractory to standard therapy or for which no proven effective therapy exists
Written informed consent
Appropriate bone marrow, hepatic and renal functions
ECOG PS =< 1

Exclusion Criteria:

Have serious preexisting complication
Have active infection which requires intravenous antibiotics
Have symptomatic central nervous system metastases
Have current acute or chronic leukemia
Have had an autologous or allogenic hematopoietic stem cell transplantation
Have active multiple cancers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Senior Manager	Kyowa Kirin Co., Ltd.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24752449	Derived	Wakui H, Yamamoto N, Kitazono S, Mizugaki H, Nakamichi S, Fujiwara Y, Nokihara H, Yamada Y, Suzuki K, Kanda H, Akinaga S, Tamura T. A phase 1 and dose-finding study of LY2523355 (litronesib), an Eg5 inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Jul;74(1):15-23. doi: 10.1007/s00280-014-2467-z. Epub 2014 Apr 22.