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出境医 / 临床实验 / Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer

Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer

Study Description
Brief Summary:
A two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer.

Condition or disease Intervention/treatment Phase
Advanced Prostate Cancer Drug: Inj. Goserelin (Test) Subcutaneously Drug: Inj. Zoladex (Reference) Subcutaneously Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Arm, Multi Centric, Randomised, Open Label, Parallel Study to Compare Pharmacodynamics of Goserelin 10.8mg Injection (Sponsor) Administered Subcutaneously With the Reference Drug ZOLADEX® 10.8mg Injection (AstraZeneca Pharmaceuticals LP) in Patients With Advanced Prostate Cancer
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : November 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Inj. Goserelin (Test) Subcutaneously
10.8 mg, Subcutaneously at every 3 month
Drug: Inj. Goserelin (Test) Subcutaneously
10.8 mg, subcutaneously at every 3 month

Active Comparator: Inj. Zoladex (Reference) Subcutaneously
10.8 mg, Subcutaneously at every 3 month
Drug: Inj. Zoladex (Reference) Subcutaneously
10.8 mg, Subcutaneously at every 3 month

Outcome Measures
Primary Outcome Measures :
  1. To evaluate and compare the pharmacodynamics of test product against reference product and establish non inferiority. [ Time Frame: 24 weeks ]
    Proportion of patients achieving castrate level of serum testosterone (Serum testosterone ≤ 0.5 ng/ml) at the end of 24 weeks


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male patient with age of 18 to 75 years (Both inclusive)
  2. Body mass index (BMI) between 18.5 and 30 kg/m². (Both inclusive)
  3. Patient with a histologically or cytologically confirmed advanced prostatic adenocarcinoma. (stage III or stage IV or recurrent metastatic disease)
  4. Serum testosterone level > 1.5 ng/mL at screening.
  5. Patient must be able to give informed consent for participation in the trial.
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  7. Adequate bone marrow function, renal function, liver function.
  8. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
  9. Patients with life expectancy of at least 1 year.
  10. Patient or his partner must have to use an effective method of contraception during the study.

Exclusion Criteria:

  1. Evidence of severe urinary tract obstruction with anticipated urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
  2. Patients with spinal cord compression (in the opinion of the Investigator), taking into account medical history, clinical observations and symptoms.
  3. Excruciating, severe bone pain which is due to extensive metastatic osseous deposits.
  4. Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy >5 years previously and have no known evidence of residual or recurrent disease.
  5. Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically-confirmed brain metastasis.
  6. Patients with a clinically significant medical condition other than advanced prostate cancer including but not limited to renal, hepatic, gastrointestinal, endocrine, cardiovascular, neurological or psychiatric disease, alcohol or substance abuse, or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator.
  7. Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
  8. History of orchiectomy, adrenalectomy or hypophysectomy
  9. Patients receiving anticoagulation medications.
  10. Patients with uncontrolled diabetes mellitus at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)
  11. Uncontrolled hypertension (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias. (Patients with hypertension controlled by antihypertensive therapies are eligible).
  12. Patients with a QTc>450ms on the ECG at screening.
  13. History of clinically significant cardiovascular disorder
  14. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol abuse within the past 1 year, as judged by the Investigator, or a positive result on the urine drug/alcohol screen which is not consistent with current medical treatment.
  15. Concomitant use of medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.
  16. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
  17. Patients who test positive for HIV and/or syphilis.
  18. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior screening or 5 half-lives within the last dose of investigational product, whichever is longer. Current use of any drugs that are known to interfere with goserelin metabolism or to cause a drug-drug interaction.
  19. Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
  20. Patients with a mental incapacity, unwillingness, or language barrier that precludes the ability to understand or cooperate with study procedures.
  21. Presence of clinically significant findings on the physical exam, laboratory testing, medical history, ECG that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
  22. Any contraindications for goserelin administration.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Cassiano Berto +551150908600 ext 8412 cassiano.berto@eurofarma.com.br
Contact: Sandra Rodrigues +551150908600 ext 8417 sandra.rodrigues@eurofarma.com.br

Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 3, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
To evaluate and compare the pharmacodynamics of test product against reference product and establish non inferiority. [ Time Frame: 24 weeks ]
Proportion of patients achieving castrate level of serum testosterone (Serum testosterone ≤ 0.5 ng/ml) at the end of 24 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer
Official Title  ICMJE A Two Arm, Multi Centric, Randomised, Open Label, Parallel Study to Compare Pharmacodynamics of Goserelin 10.8mg Injection (Sponsor) Administered Subcutaneously With the Reference Drug ZOLADEX® 10.8mg Injection (AstraZeneca Pharmaceuticals LP) in Patients With Advanced Prostate Cancer
Brief Summary A two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Prostate Cancer
Intervention  ICMJE
  • Drug: Inj. Goserelin (Test) Subcutaneously
    10.8 mg, subcutaneously at every 3 month
  • Drug: Inj. Zoladex (Reference) Subcutaneously
    10.8 mg, Subcutaneously at every 3 month
Study Arms  ICMJE
  • Experimental: Inj. Goserelin (Test) Subcutaneously
    10.8 mg, Subcutaneously at every 3 month
    Intervention: Drug: Inj. Goserelin (Test) Subcutaneously
  • Active Comparator: Inj. Zoladex (Reference) Subcutaneously
    10.8 mg, Subcutaneously at every 3 month
    Intervention: Drug: Inj. Zoladex (Reference) Subcutaneously
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male patient with age of 18 to 75 years (Both inclusive)
  2. Body mass index (BMI) between 18.5 and 30 kg/m². (Both inclusive)
  3. Patient with a histologically or cytologically confirmed advanced prostatic adenocarcinoma. (stage III or stage IV or recurrent metastatic disease)
  4. Serum testosterone level > 1.5 ng/mL at screening.
  5. Patient must be able to give informed consent for participation in the trial.
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  7. Adequate bone marrow function, renal function, liver function.
  8. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
  9. Patients with life expectancy of at least 1 year.
  10. Patient or his partner must have to use an effective method of contraception during the study.

Exclusion Criteria:

  1. Evidence of severe urinary tract obstruction with anticipated urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
  2. Patients with spinal cord compression (in the opinion of the Investigator), taking into account medical history, clinical observations and symptoms.
  3. Excruciating, severe bone pain which is due to extensive metastatic osseous deposits.
  4. Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy >5 years previously and have no known evidence of residual or recurrent disease.
  5. Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically-confirmed brain metastasis.
  6. Patients with a clinically significant medical condition other than advanced prostate cancer including but not limited to renal, hepatic, gastrointestinal, endocrine, cardiovascular, neurological or psychiatric disease, alcohol or substance abuse, or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator.
  7. Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
  8. History of orchiectomy, adrenalectomy or hypophysectomy
  9. Patients receiving anticoagulation medications.
  10. Patients with uncontrolled diabetes mellitus at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)
  11. Uncontrolled hypertension (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias. (Patients with hypertension controlled by antihypertensive therapies are eligible).
  12. Patients with a QTc>450ms on the ECG at screening.
  13. History of clinically significant cardiovascular disorder
  14. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol abuse within the past 1 year, as judged by the Investigator, or a positive result on the urine drug/alcohol screen which is not consistent with current medical treatment.
  15. Concomitant use of medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.
  16. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
  17. Patients who test positive for HIV and/or syphilis.
  18. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior screening or 5 half-lives within the last dose of investigational product, whichever is longer. Current use of any drugs that are known to interfere with goserelin metabolism or to cause a drug-drug interaction.
  19. Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
  20. Patients with a mental incapacity, unwillingness, or language barrier that precludes the ability to understand or cooperate with study procedures.
  21. Presence of clinically significant findings on the physical exam, laboratory testing, medical history, ECG that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
  22. Any contraindications for goserelin administration.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936218
Other Study ID Numbers  ICMJE EF 161
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.
Responsible Party Eurofarma Laboratorios S.A.
Study Sponsor  ICMJE Eurofarma Laboratorios S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eurofarma Laboratorios S.A.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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