A Phase 1 study of TAK-385 in Patients With Androgen Deprivation Treatment-Naive Prostate Cancer

Phase 1

• Conditions: androgen deprivation treatment-naive nonmetastatic prostate cancer

• Registration Number: JPRN-jRCT2080222485
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

1)Patient has histologically or cytologically confirmed prostate adenocarcinoma
2)Patients who have not received androgen deprivation treatment (e.g., GnRH agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer.
3)Patients who have not undergone surgical castration
4)Serum testosterone at screening > 150 ng/dL
5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

1)Patients who have received 5-alpha reductase inhibitors
2)Patients who have received chemotherapy for prostate cancer (including Estramustine)
3)Patients who have received 125I-brachytherapy radiation therapy
4)Diagnosis or treatment for another systemic malignancy within 2 years before the first dose. Patients who diagnosed with another malignancy and any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type will not be excluded if they have undergone complete resection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified