AzTrials
AzTrials

Metastatic Castration Resistant Prostate CancerPhase 1NCT03778047

A Study Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch

A Phase 1 study testing Enzalutamide and HC1119 in people with Metastatic Castration Resistant Prostate Cancer, run by Hinova Pharmaceuticals Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and related changes after drug switch in Chinese patients with metastatic castration-resistant prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide and HC1119
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
7 Feb 2018to 28 Aug 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participated in the study, with understanding of and will to comply with relevant study procedures and signed informed consent form;
  • Chinese male, ≥ 18 years old;
  • With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
  • With evidence of metastatic lesions (such as bone scan and CT/MRI);
  • 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: 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 progression as defined by PCWG2 with 2 or more new lesions on bone scan);
  • Castrate levels of testosterone (< 50 ng/dl) at screening; bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
Show all 12Show fewer
  • ECOG performance status ≤1;
  • Laboratory tests must meet the following criteria:
  • Routine Blood Test: hemoglobin (Hb) ≥ 90g/L (no blood transfusions within 14 days prior to screening); 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.
  • Estimated life expectancy > 6 months.

Who cannot join

  • Participated in other clinical drug trials within 1 month prior to screening, or the occurrence of toxicity caused by previous treatments that has not been relieved to ≤ Grade 2 toxicity (according to CTCAE 4.03) prior to enrollment;
  • Brain metastases;
  • Subjects are excluded if any of the following conditions are met:
  • Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);
  • History of organ transplants;
  • Past medical history of seizures, serious CNS diseases, or unexplained coma, family history of seizures, or history of traumatic brain injury;
Show all 18Show fewer
  • Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg) or other serious cardiovascular diseases. (Patients with a history of hypertension is eligible if his blood pressure is controlled with antihypertensives);
  • 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;
  • Other uncontrolled clinical diseases, including but not limited to: persistent or active infections.
  • Subjects are excluded if any of the following conditions regarding past or concomitant medication are met:
  • Medications that lower the seizure threshold must be used during the trial;
  • Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within 4 weeks prior to screening;
  • Treatment with ketoconazole within 4 weeks prior to screening;
  • Previously treated with investigational or approved medications that inhibit testosterone synthesis (such as abiraterone acetate, TAK-683, and TAK-448) or target testosterone receptors (such as SHR3680, proxalutamide, and ARN509), except for bicalutamide and flutamide.
  • Known hypersensitivity to any ingredient of the study drugs (enzalutamide and HC-1119) or similar drugs;
  • HIV seropositive;
  • History of medication or drug abuse;
  • Other conditions that subject is determined by the investigator to be unsuitable for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Medical Ethics Committee of Hunan Cancer Hospital

    Changsha

Other trials in China

About this study

Official title: A Clinical Study for Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer

This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and related changes after drug switch in Chinese patients with metastatic castration-resistant prostate cancer. The study primary objective is to evaluate the pharmacokinetic characteristics of enzalutamide in Chinese patients with mCRPC.

Being tested
Enzalutamide, HC1119

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03778047
Study groupRoleWhat they receive
enzalutamideExperimental160mg
Receives: Drug: Enzalutamide
HC-1119ExperimentalTo be determined
Receives: Drug: HC1119

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum drug concentration(Cmax)

    Measured: From the first dose of the study drug to 12 weeks after dose

  2. Time of maximum drug concentration(Tmax)

    Measured: From the first dose of the study drug to 12 weeks after dose

  3. Area under curve from time 0 to 24h (AUC0-24h)

    Measured: From the first dose of the study drug to 12 weeks after dose

Secondary outcomes (5)

  1. Maximum drug concentration(Cmax)

    Measured: From 13 weeks to 24 weeks after dose

  2. Time of maximum drug concentration(Tmax)

    Measured: From 13 weeks to 24 weeks after dose

  3. Area under curve from time 0 to 24h (AUC0-24h)

    Measured: From 13 weeks to 24 weeks after dose

  4. Number of patients with adverse events

    Safety measures

    Measured: From the first dose of the study drug to 24 weeks after dose

  5. Percentage of patients with > 50% decrease in prostate specific antigen (PSA)

    Percentage of patients with > 50% decrease in PSA levels from baseline at weeks1,3,5 6, 8, 10, and 12.

    Measured: From the first dose of the study drug to 12 weeks after dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start7 Feb 2018
  3. Primary completion24 Oct 2018
  4. Study completion28 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03778047
Sponsor's protocol ID
HC-1119-02
Status last verified
Oct 2020
First submitted
11 Dec 2018
Last updated
3 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Enzalutamide and HC1119 in people with Metastatic Castration Resistant Prostate Cancer, run by Hinova Pharmaceuticals Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum drug concentration(Cmax) (time frame: From the first dose of the study drug to 12 weeks after dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03778047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in