NCT03774056CompletedPhase 1
A Phase I Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients With Metastatic Castration-Resistant Prostate Cancer.
Hinova Pharmaceuticals Inc.1 site in 1 country43 target enrollmentStarted: February 10, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hinova Pharmaceuticals Inc.
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicities(DLT)
Study Overview
Brief Summary
This is a phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy of HC-1119 in patients with metastatic castration-resistant prostate cancer. The study objective is to study the tolerability, safety, and dose-limiting toxicities (DLT) of HC-1119 in patients with mCRPC.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
dose group
Experimental
Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg
Intervention: HC-1119 (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicities(DLT)
Time Frame: From the first dose of the study to the 12th week after dose
Safety measures
Number of patients with adverse events
Time Frame: From the first dose of the study to the 12th week after dose
Safety measures
Secondary Outcomes
- Maximum drug concentration(Cmax)(From the first dose of the study to the 12th week after dose)
- Time of maximum drug concentration(Tmax)(From the first dose of the study to the 12th week after dose)
- Area under curve from time 0 to 24h (AUC0-24h)(From the first dose of the study to the 12th week after dose)
- Maximal PSA Response Rate(From the first dose of the study to the 12th week after dose)
- Response rate of prostate specific antigen (PSA)(From the first dose of the study to the 12th week after dose)
Investigators
Study Sites (1)
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