A phase 1 study of K-912, nonrandomized, open label, dose escalation study in Japanese patients with solid tumors.
Phase 1
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2080222174
- Lead Sponsor
- Kowa Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients with histologically or cytologically diagnosis of solid tumor
Patients with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
Patients with adequate organ functions
Patients with 0 to 1 of ECOG Performance Status (P.S.) score
Patients with 12 weeks or more life expectancy
and so on
Exclusion Criteria
Patients with the severe complication
Patients with brain metastasis accompanying clinical symptoms
Patients with hematopoietic tumor
Patients with active infections in need of treatment for systemic
and so on
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT)<br>CTCAE ver.4.0
- Secondary Outcome Measures
Name Time Method Pharmacokinetics and anti-tumor activity<br>RECIST ver.1.1, Drug concentration measurement