A phase II study of TSU-68 in patient with metastatic colorectal cancer
Phase 2
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-jRCT2080221366
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
(1) Signed, written informed consent.
(2) Histologically or cytologically confirmed CRC.
(3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
(1) Brain metastasis or leptomeningeal metastasis confirmed by imaging study, or suspected brain metastasis.
(2) Presence of active infection.
(3) Known clinically significant interstitial lung disease or pulmonary fibrosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival<br>RECIST (ver. 1.1)
- Secondary Outcome Measures
Name Time Method Overall response rate, Overall survival, Safety<br>CTCAE (ver. 4.0)