A Study of LY2523355 in Patients With Solid Cancer

Solid Tumors Clinical Trial

— 2523355-001  

Official title:

A Phase 1 Study of LY2523355 in Patients With Solid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358019
• Other study ID #: 2523355-001
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2011
• Last updated: January 25, 2013
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• LY2523355
Days 1, 2, and 3 in a cycle that consists of 21-days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0			Yes
Primary	Number of patients with adverse events			Yes
Secondary	Pharmacokinetics	Plasma concentration of LY2523355 and metabolite		No
Secondary	Antitumor effect	Response evaluation criteria in solid tumors		No