A Study of LY2523355 in Patients With Solid Cancer (2523355-001)

A Phase 1 Study of LY2523355 in Patients With Solid Cancer

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: LY2523355

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2523355	Drug: LY2523355; Days 1, 2, and 3 in a cycle that consists of 21-days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.
• Investigators: Study Director: Senior Manager, Kyowa Kirin Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Estimate): January 28, 2013
• Last Update Submitted That Met QC Criteria: January 25, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 2523355-001