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

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: LY2523355

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358019

2523355-001

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

LY2523355

Experimental group

Treatment:

Drug: LY2523355