Metastatic Prostate Cancer (mCRPC)
Conditions
Interventions
Drug: JSB462
300 mg or 100 mg once a day (QD) with food
Sponsors
Yamauchi Kyosuke
Eligibility
Sex/Gender
Male
Inclusion criteria
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 (<50 ng/dL or <1.7 nmol/L). Ongoing ADT (as defined by prior orchiectomy and/or ongoing GnRH analog/antagonist) is allowed prior to enrollment. - Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =< 1.
Exclusion criteria
Exclusion criteria: - Patients with CNS metastases. - Patients with any other active malignancy other than prostate cancer. Exceptions to this criterion include the following: malignancies that were treated curatively at least 3 years before starting study treatment which have not recurred; basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative local therapy or other tumors that will not affect life expectancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment - Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) - Number of Participants with dose adjustments - Dose Intensity - Plasma concentrations of JSB462 and its metabolite ARV-767 - AUC of JSB462 - Cmax of JSB462 - Tmax of JSB462 | — |
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed