A Study of LY2523355 in Patients With Solid Cancer

NCT ID: NCT01358019

Last Updated: 2013-01-28

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY2523355

Group Type EXPERIMENTAL

LY2523355

Intervention Type DRUG

Days 1, 2, and 3 in a cycle that consists of 21-days

Interventions

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LY2523355

Days 1, 2, and 3 in a cycle that consists of 21-days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Senior Manager

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 24752449 (View on PubMed)

Other Identifiers

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2523355-001

Identifier Type: -

Identifier Source: org_study_id

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