EUCTR2009-017668-18-FR进行中（未招募）1 期
A Phase 1/2, Open-Label Study in Men with Prostate Cancer to Assess the Safety, Pharmacokinetics, and Testosterone-Lowering Efficacy of TAK-448, Administered as a 1 Month Depot, Including a Randomized Portion With a Group Administered Leuprorelin
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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 <30 ng/mL and if metastatic disease, asymptomatic with only bone scan positive evidence of metastases. Patients with recurrent local disease will be asymptomatic without bladder, bowel, or obstructive symptoms.
- •b) If not receiving GnRH therapy, a potential candidate for GnRH at some time in the future, i.e. in a period of ‘watchful waiting’ with generally indolent or stable disease with PSA DT >6 months and absolute PSA <30 ng/mL, and if metastatic disease, asymptomatic with only bone scan positive evidence of metastases. Patients with
- •recurrent local disease will be asymptomatic without bladder, bowel, or obstructive symptoms.
- •5. For the phase 2 portion of the study only: Evidence of progressive prostate cancer, which in the opinion of the referring physician and/or study investigator warrants the initiation of GnRH analog therapy. Such patients may have either elevated or rising PSA at least 6 months following primary local therapy(ies) or have evidence of metastatic disease not previously treated with first line hormone (GnRH analog) therapy. Patients are not eligible for inclusion if they are to receive first line hormone therapy for adjuvant/neoadjuvant therapy as part of local treatment of disease (surgery or radiation) or for primary local tumor control.
- •6. Provision of informed consent and, for the phase 1 portion of the study only, willing to participate in a phase 1 trial with no expectation of therapeutic benefit.
- •7. Generally fit medical condition, with no acute or chronic medical conditions, other than prostate cancer, affecting 2 year life expectancy.
- •a) ECOG performance status 0 or 1
- •b) New York Heart Association classification 0 to II
- •c) Serum creatinine < 1.5 ULN
- •d) If hypertensive, on 2 or fewer agents and with blood pressure adequately or well controlled (systolic <150
- •mmHg, diastolic <95 mmHg)
- •e) Hemoglobin >11.0 g/dL
- •f) Total bilirubin must be <1.5 x ULN
- •g) Generally normal laboratory evaluation, liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT]) within 2 times the ULN as reported by the central reference laboratory.
- •8. Ability to understand and comply with protocol requirements.
- •9. Agreement to, even if surgically sterilized but not surgically castrated (i.e. status postvasectomy):
- •- Practice effective barrier contraception:
- •Phase 1 portion of the study: during the entire study treatment period and through 3 months after the dose of study drug
- •Phase 2 portion of the study: during the entire study treatment period through 2 months after the last dose of study drug
- •- Abstain from heterosexual intercourse
- •10. Suitable venous access for the study-required blood sampling, i.e. including PK and pharmacodynamic sampling.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Nu
排除标准
- •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
- •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)
研究者
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