A Phase 2 study of TAS-115 in patients with CRPC
Phase 2
Completed
- Conditions
- Patient with castration resistant prostate cancer
- Registration Number
- JPRN-jRCT2080223393
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
Provided written informed consent
- Histologically confirmed prostate cancer with adenocarcinoma.
- Satisfy the following definition of castration resistance.
Castrate serum testosterone level:50 ng/dL or less
Bilateral orchiectomy or maintenance on androgen ablation therapy
with LHRH agonist or antagonist
Disease or PSA progression
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion Criteria
- A serious illness or medical condition.
- Hypersensitivity to any drugs similar to TAS-115 in structure or class.
- History of other primary malignancy in the last 5 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Efficacy<br>Bone Navi
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy, Safety<br>RECIST(Ver.1.1), PCWG3, CTCAE(Ver.4.03)