A Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients.

Phase 1

Completed

• Conditions: Metastatic Castration Resistant Prostate Cancer
• Interventions: Drug: HC-1119

• Registration Number: NCT03774056
• Lead Sponsor: Hinova Pharmaceuticals Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-10
• Primary Completion: 2018-09-26
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Completion: 2019-08-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
dose group	HC-1119	Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities(DLT)	From the first dose of the study to the 12th week after dose	Safety measures
Number of patients with adverse events	From the first dose of the study to the 12th week after dose	Safety measures

Secondary Outcome Measures

Name	Time	Method
Maximum drug concentration(Cmax)	From the first dose of the study to the 12th week after dose	Single-dose and repeated-dose
Time of maximum drug concentration(Tmax)	From the first dose of the study to the 12th week after dose	Single-dose and repeated-dose
Area under curve from time 0 to 24h (AUC0-24h)	From the first dose of the study to the 12th week after dose	Single-dose and repeated-dose
Maximal PSA Response Rate	From the first dose of the study to the 12th week after dose	Percentage of patients with \> 50% decrease in PSA levels from baseline during the 12-week treatment period
Response rate of prostate specific antigen (PSA)	From the first dose of the study to the 12th week after dose	Percentage of patients with \> 50% decrease in PSA levels from baseline at weeks 6, 8, 10, and 12.

Trial Locations

Locations (1)

Hinova Pharmaceuticals Inc.; 🇨🇳 Chengdu, Sichuan, China