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A Phase 2 study of TAS-115 in patients with CRPC

A PHASE 2, OPEN LABEL, MULTI-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF TAS-115 IN PATIENTS WITH CASTRATION RESISTANT PROSTATE CANCER (CRPC)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223393
Enrollment
50
Registered
2016-11-25
Start date
2017-01-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with castration resistant prostate cancer

Interventions

Sponsors

Taiho Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
efficacy Efficacy Bone Navi

Secondary

MeasureTime frame
safety efficacy Efficacy, Safety RECIST(Ver.1.1), PCWG3, CTCAE(Ver.4.03)

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026