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

NCT03774056 | Completed Phase 1 DMC

• 1 other identifier: HC-1119-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Castration Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities(DLT)

  Safety measures

  From the first dose of the study to the 12th week after dose

• Number of patients with adverse events

  Safety measures

  From the first dose of the study to the 12th week after dose

Secondary Outcomes (5)

• 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

Study Arms (1)

dose group

EXPERIMENTAL

Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg

Drug: HC-1119

Interventions

HC-1119 DRUG

oral

dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participated in the study, with understanding of relevant study procedures and signed informed consent form;
• Male , ≥18 years old;
• With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
• With evidence of metastatic disease (such as bone scan and CT/MRI results);
• Patients with relapsed, refractory, or progressive disease despite castration (surgery or chemical) or combined androgen deprivation therapy (Progressive disease is defined as 1 or more of the following 3 criteria: Serum PSA progression: A minimum of 3 rising PSA values with an interval of at least 1 week between determinations, resulting in a final value higher than 50% of the minimum, with a starting PSA value \> 2 ng/ml; Soft tissue disease progression as defined by RECIST 1.1; Bone disease progression defined by PCWG2 with 2 or more new metastatic lesions on bone scan);
• Castrate levels of testosterone (\< 50 ng/dl) at screening;
• Bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
• Estimated life expectancy \> 6 months;
• ECOG performance status ≤ 1;
• Laboratory tests must meet the following criteria:
• Routine Blood Test: hemoglobin (Hb) ≥ 90 g/L (no blood transfusion within the last 14 days); absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count (PLT) ≥ 80 x 109/L;
• Blood Biochemistry: creatinine (Cr) ≤ 2 x upper limit of normal (ULN), or Cr \> 2 x ULN but the calculated CrCl ≥ 60 mL/min; bilirubin (BIL) ≤ 2 x ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN (or ≤ 5.0 x ULN for patients with liver metastases);
• Coagulation: INR \< 1.5.

You may not qualify if:

• Ongoing toxicity ( ≥ Grade 2 toxicity) from previous treatments;
• Clinically significant GI dysfunction which may affect the intake, transport, or absorption of drug (such as inability to swallow, chronic diarrhea, and bowel obstruction, etc.), or patients with complete gastrectomy;
• History of allergies, or known hypersensitivity to components of the investigational drug;
• Brain metastases;
• Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);
• History of organ transplants
• HIV seropositive;
• Past medical history of seizures or serious CNS diseases;
• History of unexplained coma;
• Family history of seizures;
• History of traumatic brain injury;
• History of medication or drug abuse;
• Patients with severe cardiovascular diseases, including those with myocardial infarction, arterial thrombosis, unstable angina, or clinical symptomatic heart failure within the past 6 months;
• Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg). Patients with a history of hypertension is eligible if his blood pressure is controlled with antihypertensives;
• Medications that lower the seizure threshold must be used during the study;

Sponsors & Collaborators

• Hinova Pharmaceuticals Inc.: lead
• West China Hospital: collaborator

Study Sites (1)

Hinova Pharmaceuticals Inc.

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• Li X, Cheng K, Li X, Zhou Y, Liu J, Zeng H, Chen Y, Liu X, Zhang Y, Wang Y, Bi F, Zheng L. Phase I clinical trial of HC-1119: A deuterated form of enzalutamide. Int J Cancer. 2021 Oct 1;149(7):1473-1482. doi: 10.1002/ijc.33706. Epub 2021 Jul 7.

  PMID: 34109624 DERIVED

MeSH Terms

Interventions

enzalutamide

Study Officials

• Feng Bi, professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Li Zheng, professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 12, 2018
• Study Start: February 10, 2017
• Primary Completion: September 26, 2018
• Study Completion: August 28, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

CN (1)