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Phase I Study of TAS-115 in Patients with Advanced Solid Tumors

Phase 1
Conditions
Patients with advanced solid tumor
Registration Number
JPRN-jRCT2080221605
Lead Sponsor
Taiho Pharmaceutical Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
85
Inclusion Criteria

Signed, written informed consent.
- Histologically or cytologically confirmed solid tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria

- Investigational drug therapy within 28 days prior to enrollment.
- Radiotherapy within 21 days prior to enrollment.
- Received extensive prior radiotherapy on more than 30% of bone marrow.
- Females who are pregnant or breastfeeding.
- Serious complications.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety<br>CTCAE (ver.4.03)
Secondary Outcome Measures
NameTimeMethod
Pharmacokinetics, Efficacy<br>RECIST (ver.1.1)
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