A Study of LY2523355 in Patients With Solid Cancer
- Registration Number
- NCT01358019
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LY2523355 LY2523355 -
- Primary Outcome Measures
Name Time Method Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0 Number of patients with adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Plasma concentration of LY2523355 and metabolite
Antitumor effect Response evaluation criteria in solid tumors