EUCTR2014-003642-26-GB进行中（未招募）1 期
SAFETY AND PHARMACOKINETICS OF ODM-204 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC): OPEN, NONRANDOMISED, UNCONTROLLED, MULTICENTRE, DOSE ESCALATION, FIRST-IN-MAN STUDY WITH A DOSE EXPANSION - Dualides phase 1/2 study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
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
- •1. Written informed consent (IC) obtained.
- •2. Male aged = 18 years.
- •3. Histologically or cytologically confirmed adenocarcinoma of prostate.
- •4. Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl], 0.5 ng/ml) on GnRH agonist or antagonist therapy, or after bilateral orchiectomy. Patients who have not undergone bilateral orchiectomy must continue GnRH therapy during the study.
- •5. Metastatic disease documented by bone scan, CT or magnetic resonance imaging (MRI).
- •6. Prostate cancer progression documented by one or more of the following criteria:
- •PSA progression defined by a minimum of 2 rising PSA levels with an interval of at least 1 week between each determination. The PSA value at the screening visit should be = 2 ng/ml.
- •- soft tissue disease progression as defined by RECIST 1.1 criteria
- •- bone disease progression defined by PCWG2 criteria (2 or more new lesions on bone scan compared with prior scan).
- •7. ECOG performance status 0-2.
- •8. Estimated life expectancy of at least 3 months.
- •9. Blood counts at screening:
- •- haemoglobin = 10 g/dl
- •- absolute neutrophil count = 1500/µl (1.5x10?/l)
- •- platelet count = 100,000/µl (100x10?/l )
- •The subject must not have received any growth factor or blood transfusion within 7 days of the haematology laboratory values obtained at the screening visit.
- •10. Liver, renal and albumin values at screening:
- •- ALT and AST = 2.5 x ULN
- •- total bilirubin = 1.5 x ULN (except for subjects with a diagnosis of Gilbert’s disease)
- •- creatinine = 1.5 x ULN
- •- albumin > 3.0 g/dl.
- •11. Serum potassium = 3.5 mmol/l.
- •12. Able to swallow study treatments and comply with study requirements.
- •13. Acceptable and regular bowel movements in the judgement of the investigator without any acute, subacute or chronic gastrointestinal (GI) obstruction or other GI disorder or procedure which may interfere significantly with absorption of study treatment.
- •14. Sexually active subjects, unless surgically sterile, must agree to use condoms and an additional effective contraception method during the study treatment and for 3 months after the end of the study treatment.
- •15. Patients on systemic glucocorticoids for the treatment of prostate cancer or control of symptoms must have documented PSA progression by PCWG2 criteria prior start of study treatment. Patients with confirmed PSA progression while on systemic corticosteroids
- •other than Prednison® are required to switch to Prednison® 5 mg (once or twice a day depending on the previous glucocorticoid dose) prior the start of study treatment, but PSA progression does not have to be reconfirmed.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. History of pituitary or adrenal dysfunction.
- •2. Known brain metastases.
- •3. Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
- •4. Poorly controlled diabetes as judged by the investigator.
- •5. Prior therapy with any investigational CYP17A1i (e.g. TAK-700, TOK-001) or any investigational second-generation AR inhibitors (e.g. ARN-509, ODM-201).
- •6. Depending upon patient’s prior treatment, the following apply:
- •- prior chemotherapy: not more than 2 prior chemotherapy treatments are allowed; chemotherapy is not allowed within 4 weeks before the start of the study treatment
- •- prior abiraterone therapy must have been stopped at minimum 2 weeks before the start of the study treatment
- •- prior second-generation AR inhibitor therapy must have been stopped at minimum 4 weeks before the start of the study treatment.
- •8. Use of first-generation AR inhibitor within 4 weeks (within 6 weeks for bicalutamide and nilutamide) before start of the study treatment.
- •9. Systemic therapy with ketoconazole, or any other azole drug (e.g. fluconazole, itraconazole) within 4 weeks before the start of the study treatment.
- •10. Use of estrogens, cyproterone acetate, 5-a reductase inhibitors (finasteride, dutasteride) or biologic treatment within 4 weeks before the start of the study treatment. Prior radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks before start of study treatment.
- •11. Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 4.03) grade of = 1. Chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed.
- •12. Initiation of an osteoclast-targeted therapy (bisphosphonate or denosumab) within 4 weeks before the start of the study treatment. Patients on a stable dose of osteoclast-targeted therapy for at least 4 weeks before the start of the study treatment can continue the
- •treatment during the study.
- •13. Participation in another interventional clinical trial and any concurrent treatment with any other investigational drug except those mentioned in exclusion criterion 7 within 4 weeks before start of the study treatment.
- •14. Uncontrolled hypertension
- •? systolic BP = 160 mmHg or
- •? diastolic BP = 95 mmHg.
- •Subjects with history of hypertension can be included, provided that BP is controlled by
- •anti-hypertensive therapy.
- •15. Clinically significant heart disease as judged by the investigator, e.g. congestive heart
- •failure New York Heart Association (NYHA) class = 3, myocardial infarction,
- •thrombotic or embolic event in the past 6 months, or unstable angina.
- •16. Prolonged QTc interval as evidenced by:
- •? history or family history of long QTc syndrome
- •? prolonged QT interval corrected by the Fridericia correction formula (QTcF) > 450 ms
- •on the centrally-read ECG at screening (2 of the measurements at screening > 450 ms).
- •17. Major surgery within 4 weeks before the start of the study treatment.
- •18. History of significant bleeding disorder unrelated to cancer, including:
- •? diagnosed congenital bleeding disorders (e.g. von Willebrand’s disease)
- •? diagnosed acquired bleeding disorder (e.g. acquired anti-factor VIII antibodies) within
- •1 year of screening visit
- •? history of GI bleeding within 6 months of the screening visit.
- •19. Severe or uncontrolled concurrent medical condition or psychiatric illness.
- •20. Serious persistent infection within 2 weeks before the start of the study treatment.
研究者
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