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Pharmacodynamic Study of Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT03936933
Recruitment Status : Unknown
Verified May 2019 by Eurofarma Laboratorios S.A..
Recruitment status was:  Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
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 February 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 [ Time Frame: 85 days ]
Percentage of patients with a mean estradiol concentration <30 pg/mL at day 85 days (EOS)
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 Pharmacodynamic Study of Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients With Advanced Breast Cancer
Official Title  ICMJE A Two Arm, Multi Centric, Randomized, Open Label, Parallel, Multiple Dose Pharmacodynamic Study of Goserelin 3.6 mg Injection (Eurofarma) Administered Subcutaneously in Comparison With the Reference Drug ZOLADEX® 3.6 mg Injection (AstraZeneca Pharmaceuticals LP) Administered Subcutaneously in Premenopausal Patients With Advanced Breast Cancer
Brief Summary A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Goserelin acetate 3.6 mg Injection Eurofarma Laboratorios S.A Dose: 3.6 mg, Subcutaneously at every 28 days

Reference product -R ZOLADEX® 3.6mg Injection. Dose: 3.6 mg, Subcutaneously at every 28 days

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Breast Cancer
Intervention  ICMJE
  • Drug: Goserelin acetate 3.6 mg Injection
    3.6 mg, Subcutaneously at every 28 days
  • Drug: ZOLADEX® 3.6mg Injection
    3.6 mg, Subcutaneously at every 28 days
Study Arms  ICMJE
  • Experimental: Goserelin acetate 3.6 mg Injection
    3.6 mg, Subcutaneously at every 28 days
    Intervention: Drug: Goserelin acetate 3.6 mg Injection
  • Active Comparator: ZOLADEX® 3.6mg Injection.
    3.6 mg, Subcutaneously at every 28 days
    Intervention: Drug: ZOLADEX® 3.6mg Injection
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 February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pre-menopausal* female patients of 18 to 50 years of age (both inclusive)

    * Premenopausal female is defined by one of the following criteria: menstruating actively (< 4 months since last menstrual period [LMP]) or between 4 and 12 months after LMP with a premenopausal FSH level; patients younger than 50 years of age who became amenorrheic while on adjuvant chemotherapy will be eligible only if the FSH level is in the premenopausal range (<22.3 IU/litre). [1]

  2. BMI 18.5 to 30 kg/m2 (both inclusive).
  3. Patient with a confirmed diagnosis of advanced breast cancer (stage III or stage IV or recurrent metastatic disease)
  4. Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  6. Patients with life expectancy of at least 3 months.
  7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
  8. Patient should be able to comply with study requirement in the opinion of Investigator.
  9. Non-smoker defined as non-smoker for at least 6 months (i.e. subject has not smoked or used any tobacco products for the 6 months prior to the screening visit).
  10. Patients must not have taken any anti-androgens, estrogen, antiestrogen, selective estrogen receptor modulators, aromatase inhibitors or hormonal forms of contraception within past one month of screening. Patient may have had recent use of oral contraceptive pills but these must be discontinued 30 days prior to dosing.

Exclusion Criteria:

  1. Patients who are not able to provide written informed consent.
  2. Patients who are menopausal
  3. Patients who are pregnant or breastfeeding.
  4. Concurrent malignancy or history of malignancy (apart from disease condition under study) within last 5 years before screening except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
  5. Patients with a clinically significant medical condition other than advanced breast 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.
  6. Presence of clinically significant physical exam, laboratory, medical history, ECG/echocardiogram findings that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
  7. Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
  8. Patients receiving anticoagulation medications.
  9. Patients with uncontrolled diabetes mellitus at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)
  10. Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically-confirmed brain metastasis.
  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.
  23. Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) throughout the trial and for 4 weeks after the last dose of study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (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 NCT03936933
Other Study ID Numbers  ICMJE EF 160
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 May 2019

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