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A Phase 1 Study of LY2523355 in Patients With Solid Cancer


Phase 1
20 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

A Phase 1 Study of LY2523355 in Patients With Solid Cancer


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Senior Manager

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

2523355-001

NCT ID:

NCT01358019

Start Date:

May 2011

Completion Date:

January 2013

Related Keywords:

  • Solid Tumors

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