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

Sponsor
Hinova Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03778047
Collaborator
(none)
10
1
2
18.6
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Study Details

Study Description

Brief 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. The study primary objective is to evaluate the pharmacokinetic characteristics of enzalutamide in Chinese patients with mCRPC.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 7, 2018
Actual Primary Completion Date :
Oct 24, 2018
Actual Study Completion Date :
Aug 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: enzalutamide

160mg

Drug: Enzalutamide
oral

Experimental: HC-1119

To be determined

Drug: HC1119
oral

Outcome Measures

Primary Outcome Measures

  1. Maximum drug concentration(Cmax) [From the first dose of the study drug to 12 weeks after dose]

  2. Time of maximum drug concentration(Tmax) [From the first dose of the study drug to 12 weeks after dose]

  3. Area under curve from time 0 to 24h (AUC0-24h) [From the first dose of the study drug to 12 weeks after dose]

Secondary Outcome Measures

  1. Maximum drug concentration(Cmax) [From 13 weeks to 24 weeks after dose]

  2. Time of maximum drug concentration(Tmax) [From 13 weeks to 24 weeks after dose]

  3. Area under curve from time 0 to 24h (AUC0-24h) [From 13 weeks to 24 weeks after dose]

  4. Number of patients with adverse events [From the first dose of the study drug to 24 weeks after dose]

    Safety measures

  5. Percentage of patients with > 50% decrease in prostate specific antigen (PSA) [From the first dose of the study drug to 12 weeks after dose]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Voluntarily participated in the study, with understanding of and will to comply with relevant study procedures and signed informed consent form;

  2. Chinese male, ≥ 18 years old;

  3. With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;

  4. With evidence of metastatic lesions (such as bone scan and CT/MRI);

  5. 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);

  6. Castrate levels of testosterone (< 50 ng/dl) at screening; bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;

  7. ECOG performance status ≤1;

  8. Laboratory tests must meet the following criteria:

  9. 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;

  10. 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);

  11. Coagulation: INR < 1.5.

  12. Estimated life expectancy > 6 months.

Exclusion Criteria:
  1. 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;

  2. Brain metastases;

  3. Subjects are excluded if any of the following conditions are met:

  4. Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);

  5. History of organ transplants;

  6. Past medical history of seizures, serious CNS diseases, or unexplained coma, family history of seizures, or history of traumatic brain injury;

  7. 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);

  8. 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;

  9. Other uncontrolled clinical diseases, including but not limited to: persistent or active infections.

  10. Subjects are excluded if any of the following conditions regarding past or concomitant medication are met:

  11. Medications that lower the seizure threshold must be used during the trial;

  12. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within 4 weeks prior to screening;

  13. Treatment with ketoconazole within 4 weeks prior to screening;

  14. 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.

  15. Known hypersensitivity to any ingredient of the study drugs (enzalutamide and HC-1119) or similar drugs;

  16. HIV seropositive;

  17. History of medication or drug abuse;

  18. Other conditions that subject is determined by the investigator to be unsuitable for this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Ethics Committee of Hunan Cancer Hospital Changsha China

Sponsors and Collaborators

  • Hinova Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hinova Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT03778047
Other Study ID Numbers:
  • HC-1119-02
First Posted:
Dec 19, 2018
Last Update Posted:
Nov 3, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2020