Solid Tumors
Conditions
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.
Interventions
DRUGLY2523355
Days 1, 2, and 3 in a cycle that consists of 21-days
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0 | — |
| Number of patients with adverse events | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | — | Plasma concentration of LY2523355 and metabolite |
| Antitumor effect | — | Response evaluation criteria in solid tumors |
Countries
Japan
Outcome results
None listed