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Active Not Recruiting
NCT07174063
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Conditions: Metastatic Prostate Cancer (mCRPC)
Sex: Male
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 6
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Nagoya Aichi-ken
Summary
This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.
Eligibility Criteria
Key Inclusion Criteria:
* Adult male patients with histologically or cytologically confirmed and documented adenocarcinoma of the prostate.
* At least 1 bone or visceral metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to enrollment. Lymph nodes as only site of metastases are not allowed.
* Patients with prostate cancer must have failed or refused available standard therapies, be intolerant or ineligible to receive such therapy, or for whom no standard therapy exists.
* Patients must have a castrate level of serum/plasma testosterone (\
Source: ClinicalTrials.gov (NCT07174063). StuddyBuddy aggregates publicly available trial information.
