Overview

Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

Status:
Completed
Trial end date:
2018-01-02
Target enrollment:
0
Participant gender:
Male
Summary
This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CMX Research
Collaborators:
Peptigroupe Inc
Peptigroupe Inc.
Treatments:
Goserelin
Testosterone
Criteria
Inclusion Criteria:

- Be male at least 18 years of age

- Be an ambulatory patient with carcinoma of the prostate (high risk localized or
metastatic) documented by available prostate biopsy information, who in the opinion of
the treating physician, is a candidate for androgen deprivation therapy

- Have a testosterone level > 1.5ng/mL or >5nmol/L at screening

- Have a life expectancy of at least 1 year

- Have the ability to understand the requirements of the study and is willing to provide
written informed consent

- Agree to abide by the study restrictions and return for the required assessments

- only patients who can be discontinued safety from contra-indicated medications
discussed in section 7.4 of the protocol can be included in the study

Exclusion Criteria:

- Have brain metastases

- Have vertebral metastases with evidence of spinal cord compression

- Have renal impairment due to ureteric obstruction or a history of obstructive uropathy

- Have excruciating, sever bone pain due to extensive bone metastases (however,
concomitant therapy with either flutamide or bicalutamide is permitted and encouraged
during the first month of the study, in the case where mile bone metastasis are
present or suspected)

- Undergone orchiectomy, adrenalectomy or hypophysectomy

- Have undergone prostatic surgical procedures (e.g. radical prostatectomy,
transurethral resection of the prostate) within the last month

- Have undergone localized external beam radiotherapy, brachytherapy, thermotherapy or
cryotherapy within the last 4 weeks

- Undergone systemic chemotherapy, immunotherapy (e.g. antibody therapies,
tumor-vaccines) or biological response modifiers (e.g. cytokines) within the last 3
months

- Have been treated with 5-alpha-reductase inhibitors (e.g finasteride (Proscar®,
Propecia®), dutasteride (Avodart®)) within the last month

- Have been previously treated with luteinizing hormone releasing hormone agonists
(LHRHa) (e.g. leuprolide (Lupron®), goserelin (Zoladex®) etc.) except if their
testosterone levels are above 5 nmol/L and the patient in a known responder

- Have and ongoing treatment with androgen receptor (AR) blockers (e.g. megestrol
(Megace®) or cyproterone (Androcur®). Note: Treatment with bicalutamide (Casodex®) IS
permitted.

- Have a known hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists,
any Luteinizing Hormone-Releasing Hormone (LHRH) agonists (e.g. leuprolide (Lupron®),
goserelin (Zoladex®) etc.) or to the poly(lactic-co-glycolic acid (PLGA)) polymers
contained in the study formulation

- Have a liver disease (e.g. cirrhosis, chronic active hepatitis or chronic persistent
hepatitis) or has persistent alanine amino-transferase (ALT), aspartate
amino-transferase (AST) > 2 X upper limit normal (ULN), serum creatinine > 2 X ULN,
serum bilirubin > 2 X ULN

- Have received an investigational drug or participated in a clinical trial within the
last 30 days

- Have a clinically serious and/or unstable intercurrent infection, medical illnesses or
conditions that are uncontrolled or whose control, in the opinion of the Investigator,
may be jeopardized by participation in this study or by the complications of this
therapy

- Have a body mass index (BMI) < 18.5

- Be an anticoagulated patient with an International Normalized Ratio (INR) ≥ 2

- Have a history of QT prolongation, congenital long QT syndrome, electrolyte
abnormalities, Congestive Heart Failure (CHF), or concurrent administration with QT
prolonging drugs or QTc > 450 msec