Prostate cancer MedDRA version: 17.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Camurus AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men =40 and =85 years of age 2. Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy (Classification of Malignant Tumours [TNM] stages: T3-4 NX M0, T1-4N1-3 M0 and T1-4 NX-3 M1 equivalent to the American Urology Association stages : C1/C2 and D1/D2) 3. Life expectancy over 12 months 4. World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2 5. Adequate and stable renal function i.e. serum creatinine =1.6 times the upper limit of normal (ULN) at Screening visit 6. Adequate and stable hepatic function i.e. serum bilirubin =1.5 times the ULN, and aspartate aminotransferase/serum glutamate oxaloacetate transaminase (ASAT/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALAT/SGPT) =2.5 times the ULN at Screening visit 7. Able to provide written informed consent to participate in the study and able to understand the procedures and study requirements 8. Willing and able to comply with the study requirements and complete the study assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction 2. S-T levels below 150 ng/dL at Screening visit 3. Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit 4. Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit 5. Known hypersensitivity to luteinizing hormone releasing hormone (LHRH) agonists or other components of CAM2032 q1m or Eligard 7.5 mg 6. Prior orchiectomy, hypophysectomy, or adrenalectomy 7. Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study 8. Proven lack of efficacy when treated with LHRH agonists 9. Use of finasteride within 3 months prior to the Screening visit 10. Anticipated need of any other concomitant therapy for prostate cancer for the duration of the study 11. Use of alternative medicinal therapies with estrogenic, androgenic or anti-androgenic effects within 3 months prior to the Screening visit 12. Ketoconazole or corticoids, oral/parenteral formulations within 2 months prior to the Screening visit 13. Diagnosis of any other cancer without a history of stability/remission within 5 years prior to the Screening visit, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin 14. Clinically significant laboratory test result that, in the opinion of the investigator, could compromise the patient’s welfare, or otherwise contraindicate study participation 15. Clinically significant unstable cardiac, respiratory, neurological, immunological, endocrinological, haematological, hepatic, bile duct, urological, or renal disease or any other condition that, in the opinion of the investigator, could compromise the patient’s welfare, or otherwise contraindicate study participation 16. Tested positive for human immunodeficiency virus (HIV), Hepatitis B or C 17. History of drug and/or alcohol abuse within 1 year prior to the Screening visit and/or positive urine drug test at Screening visit 18. Considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator’s Brochure (IB) for CAM2032 q1m) to be an unsuitable candidate to receive the study medication 19. Likely to be of poor protocol compliance, as judged by the investigator 20. Any other condition or deviation that, in the investigator’s opinion, makes the patient unsuitable for participation in the study 21. Participation in another study of investigational drugs or devices parallel to, or less than 30 Days before the Screening visit, or previous enrolment in this study 22. Employee of the investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the investigator or study site, or is a family member of an employee or of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the PK profiles after repeated administration of CAM2032 q1m, at doses of 3.75 mg and 7.5 mg leuprolide acetate, in patients with prostate cancer;Secondary Objective: - To assess and compare the PK profiles after repeat subcutaneous injections of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg - To assess the relative bioavailability of leuprolide when administered as repeat doses of CAM2032 q1m 3.75 mg and 7.5 mg vs. when administered as the active comparator Eligard® 7.5 mg - To assess and compare the PD profiles of s-T levels after repeat doses of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg - To assess time to T recovery after the last dose of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg - To assess the effect of repeat doses of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg, on serum prostate specific antigen (s-PSA) levels - To assess and compare safety of repeat doses of CAM2032 q1m, 3.75 mg and 7.5 mg vs. Eligard 7.5 mg;Primary end point(s): PK parameter estimates for characterizing the PK-profiles after first injection of study medication are: Cmax, Ctrough, Cmin, tmax, ?z, t½, AUClast, AUCtau, AUCinf, AUC24h, AUC7d, Cavg and %Fluctuation, and after the third injection of study medication: Cmax, Ctrough, Cmin, tmax, ?z, t½, AUClast, AUCtau, Cavg and %Fluctuation;Timepoint(s) of evaluation of this end point: After first injection of study medication and after the third injection of study medication (see E.5.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The profiles of s-T concentration (ng/dL), following each injection of the study medication. - Proportion of patients with s-T below 50 ng/dL from day 28 to 84, i.e. during the second and third dose periods. - Time to s-T recovery: the end of s-T suppression below 50 ng/dL after last injection of the study medication. - Time to s-T suppression below 50 ng/dL. - Duration of suppression of s-T below 50 ng/dL after injection of the study medication. - Days of suppression of s-T below 50 ng/dL after repeated injection of the study medication. - Number of occasions when the s-T exceeds 50 ng/mL and percentage of patients with s-T control escapes after injection of study medication. - S-PSA (ng/ml) response to study medication.;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Finland, Hungary
Contacts
Public ContactCRA
TFS Trial Form Support Kft
Outcome results
None listed