Solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : LY2523355
INN of investigational material : litronesib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigation
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| Tolerability assessment: Dose limiting toxicity Safety assessment: Adverse events, clinical laboratory test data and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Plasma concentration of LY2523355 and metabolite Antitumor effect: Response evaluation criteria in solid tumors | — |
Outcome results
None listed