Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Goserelin

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.