Phase I/II study of YHI-1001 in combination with Docetaxel in patients with advanced, metastatic or recurrent non-small cell lung cancer who have received platinum-based chemotherapy
Phase 1
- Conditions
- Patients with non-small cell lung cancer who have received platinum-based chemotherapy
- Registration Number
- JPRN-jRCT2080222077
- Lead Sponsor
- Yakult Honsha Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 118
Inclusion Criteria
(1)Patients with histologically or cytologically confirmed non-small cell lung cancer
(2)Patients who have received platinum-based chemotherapy
(3)Patients with ECOG PS of 0-1
(4)Patients who are able to take YHI-1001 orally and do not have GI dysfunction impacting on abosorption of YHI-1001
Exclusion Criteria
(1)Patients who have taken HDAC inhibitors or Docetaxel
(2)Patients with uncontrolled intercurrent illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PI:Safety<br>PII:Efficacy
- Secondary Outcome Measures
Name Time Method PI:PK<br>PII:Safety