Clinical trial NCT03523442: A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
Official title: A Phase 1 Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Subjects With Metastatic Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prostatic Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-05-14
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 to the first dose of study drug, whichever is longer, with a maximum of 4 weeks.
* Prior treatment with second-generation anti-androgens (example \[eg\], enzalutamide)
* Administration of an investigational therapeutic within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. And participant use radiopharmaceutical agents (eg, strontium-89) or investigational immunotherapy (eg, sipuleucel-T) within 12 weeks prior to the first dose of study drug
* Prior treatment with cytochrome 17 inhibitors (eg, abiraterone acetate, orteronel, galeterone, systemic ketoconazole)

Primary outcomes:
measure: 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
measure: Number of Participants with Adverse Events
timeFrame: Up to 30 days of last study treatment (approximately 18 months)
Secondary outcomes:
measure: Change from Baseline in Serum Prostate Specific Antigen (PSA) at Weeks 4 and 12
timeFrame: Baseline, at Weeks 4 and 12 or earlier for those who discontinue therapy (up to approximately 4 months).
measure: Maximal Decline in Prostate Specific Antigen
timeFrame: Up to 30 days of last study treatment (approximately 18 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital of Peking University
city: NanJing
country: China
facility: Jiangsu Cancer Hospital
city: ShangHai
country: China
facility: Fudan Cancer Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: