A Phase 1 Study of LY2523355 in Patients with Solid Cancer
Phase 1
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2080221457
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability assessment: Dose limiting toxicity<br><br>Safety assessment: Adverse events, clinical laboratory test data and vital signs
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Plasma concentration of LY2523355 and metabolite<br><br>Antitumor effect: Response evaluation criteria in solid tumors