A phase I study of YHI-1001
Phase 1
- Conditions
- Solid Tumor
- Registration Number
- JPRN-jRCT2080221834
- Lead Sponsor
- Yakult Honsha Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
(1)Patients with histologically and cytologically confirmed solid tumors
(2)Patients who have completed conventional therapies for their tumors or patients with tumors for which no conventional therapy exists
(3)ECOG performance status (PS) :0-1
(4) Patients who are able to take YHI-1001 orally and do not have GI dysfunction judged to have impact on abosorption of YHI-1001
Exclusion Criteria
(1)Patients who have taken HDAC inhibitors
(2)Patients with significant cardiovascular disease
(3)Patients with symptomatic brain metastatis requiring treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>CTCAE v4.0
- Secondary Outcome Measures
Name Time Method efficacy, pharmacokinetics and pharmacodynamics profile <br>RECIST ver1.1