NCT01358019

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

May 17, 2011

Last Update Submit

January 25, 2013

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0

  • Number of patients with adverse events

Secondary Outcomes (2)

  • Pharmacokinetics

  • Antitumor effect

Study Arms (1)

LY2523355

EXPERIMENTAL
Drug: LY2523355

Interventions

LY2523355DRUG

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

LY2523355

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 24752449DERIVED

MeSH Terms

Interventions

litronesib

Study Officials

  • Senior Manager

    Kyowa Kirin Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

JP(1)