A phase I study of TSU-68 in patient with metastatic colorectal cancer
Phase 1
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-jRCT2080221365
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
(1) Signed, written informed consent.
(2) Histologically or cytologically confirmed colorectal adenocarcinoma.
(3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
(1) Symptomatic brain metastasis.
(2) Chronic nausea, vomiting or diarrhea considered to be clinically significant by the Investigator's opinion.
(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 Safety (dose limiting toxicity)<br>CTCAE (ver. 3.0)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics, Efficacy<br>RECIST (ver. 1.0)