Prostate cancer MedDRA version: 12.1 Level: LLT Classification code 10007113 Term: Cancer of prostate
Conditions
Interventions
Product Name: TAK-448-SR (1M)
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: TAK-448
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Millennium Pharmaceuticals, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The following criteria must be met by each patient to be eligible for the phase 1 or phase 2 portion of the study, unless otherwise specified: 1. Male 40 to 72 years of age, inclusive. 2. Histologically-confirmed adenocarcinoma of the prostate, having completed primary local treatment at least 6 months prior to screening. 3. Screening serum PSA concentration > 2 ng/mL. 4. For the phase 1 portion of the study only: Either a) Concurrent GnRH therapy with generally indolent or stable disease with PSA DT >6 months and absolute PSA 6 months and absolute PSA 11.0 g/dL f) Total bilirubin must be =65 years) yes F.1.3.1 Nu
Exclusion criteria
Exclusion criteria: 1. Advanced or symptomatic metastatic prostate cancer requiring immediate GnRH or additional hormone (CAB) therapy or requiring chemotherapy 2. History of surgical castration 3. Any history of nonskin cancer, other than prostate cancer, requiring active treatment within the 2 years prior to screening 4. Any history of cardiac surgery, within the previous 6 months or any planned elective surgeries, other than skin surgery, during the ensuing 6 months 5. Any compromise of bone marrow function that would reduce tolerance to repeated blood draws 6. Any history of osteoporosis, unless actively controlled with treatment, or history of vertebral or femoral fracture within the past year 7. Any history of seizures or currently on anticonvulsant medications 8. Any history of major psychiatric illness, eg, diagnosed psychosis or psychiatric illness requiring hospitalization within the previous year 9. Any history of drug or significant alcohol abuse 10. Any participation in clinical trials or receipt of any experimental therapy within 2 months of screening 11. Serious infection within 14 days before the first dose of study drug 12. Known human immunodeficiency virus positive 13. Known hepatitis B surface antigen-positive (HBsAg), or known or suspected active hepatitis C infection 14. Any of the following cardiovascular conditions or values at the time of screening unless otherwise specified: • History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 ( CTCAE version 4.02(13)), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Atrial fibrillation on anticoagulant therapy is not allowed. • QTc > 500 milliseconds. • Abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant. In addition, for the phase 2 portion of the study, patients must not have any of the following exclusion criteria: 15. Participation in the phase 1 portion of the study 16. Prior or current use of a GnRH analog or androgen receptor antagonist as first-line hormone therapy (ie, other than as neoadjuvant/adjuvant use) 17. History of use of GnRH analog or antagonist (as adjuvant or neoadjuvant therapy) within the 6 months prior to screening 18. History of known or documented primary failure of GnRH analog therapy 19. History of rising PSA or disease progression while on a GnRH analog or CAB therapy (ie, rising PSA while on neoadjuvant/adjuvant therapy) 20. Screening serum testosterone concentration < 150 ng/dL (5.25 nmol/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Protocol phase 1: - To assess the safety and pharmacokinetics of TAK 448 in patients receiving a single dose of a 1 month depot formulation of TAK-448 Protocol phase 2: - To assess the safety in patients receiving repeated doses of a 1-month depot formulation of TAK-448 - To assess the effect of repeated doses of a 1 month depot formulation of TAK 448 on serum testosterone concentrations - To assess the pharmacokinetics of TAK 448 in patients receiving multiple doses of a 1 month depot formulation of TAK-448;Secondary Objective: Protocol phase 1: - In patients not on concomitant GnRH agonist therapy: to assess the effect of a 1 month depot formulation of TAK-448 on serum testosterone and luteinizing hormone (LH) Protocol phase 2: - To assess the effect of a 1-month depot formulation of TAK 448 on serum PSA concentration;Primary end point(s): Phase 1 of the protocol: - Safety (vital signs, 12-lead ECG, clinical laboratory tests, injection site-related skin reactions, adverse events) - Pharmacokinetics of TAK-448 (Cmax on Day 1, AUC(0-24h), AUC(0-29 days), AUC(0-last), time of last quantifiable concentration) Phase 2 of the protocol: - Safety (vital signs, 12-lead ECG, clinical laboratory tests, injection site-related skin reactions, adverse events) - Pharmacodynamics (serum testosterone level and proportion of patients below castrate-level serum testosterone on Day 1 of each month of therapy) - Pharmacokinetics of TAK-448 (AUC(0-end of month 1), trough concentration on Day 1 of each month of therapy) | — |
Countries
Belgium, France
Outcome results
None listed