A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic … (NCT03523442) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
China19 participantsStarted 2018-08-31
Plain-language summary
The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
* Metastatic disease as documented by bone scan or metastatic lesions by computed tomography or magnetic resonance imaging scans (visceral or lymph node disease). Lymph nodes in the pelvis must measure at least 1.5 centimeter in a short axis to be considered target lesion according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on the Prostate Cancer Working Group 2 (PCWG2) criteria
* Castration-resistant prostate cancer (PC) demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of prostate-specific antigen (PSA), at least 1 week apart, with the last PSA greater than or equal to (\>=) 2 nanogram per milliliter (ng/mL)
* Prior hormonal interventions (including 1st generation antiandrogens \[flutamide, bicalutamide, nilutamide\], steroids, estrogens, finasteride, dutasteride) for PC are allowed. These therapies, except for gonadotropin releasing hormone analogs (GnRH) analogs and prednisone/prednisolone, must have been discontinued for minimally 4 weeks (2 weeks only for flutamide, nilutamide, or finasteride) before first dose of study drug
Exclusion Criteria:
* Known brain metastases
* Chemotherapy, or immunotherapy within 2 weeks or 5 half-lives of the drug prior …
What they're measuring
1
Plasma Concentration of Apalutamide
Timeframe: Predose; postdose up to 168 hours (hrs) (Cycle1 Day 7), Cycle 2 (pre-dose; on Day 1 and 15 of cycle 2) and Cycle 3 (pre-dose; up to 24 hrs post-dose). Each cycle is of 28 days
2
Number of Participants with Adverse Events
Timeframe: Up to 30 days of last study treatment (approximately 18 months)