EUCTR2017-000560-15-FR进行中（未招募）1 期
Intra-individual dose escalation of abiraterone acetate according to its plasma concentration in patients with progressive castration-resistant metastatic prostate cancer - OPTIMABI
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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
- •- Male 18 years and older.
- •- Voluntary signed informed consents of the patient
- •- Histologically confirmed prostate adenocarcinoma.
- •- Presence of bone and/or soft-tissue and/or visceral metastases through CT scan, MRI, or scintigraphy scan.
- •- Progressive disease assessed by PSA, CT scan, MRI or bone scan according to the PCGW3 criteria
- •- Patient with no or moderate symptoms (no need for continuous opioid treatment)
- •- Effective castration confirmed by testosterone plasma level < 50 ng/mL
- •- ECOG performance status: 0-2
- •- Life expectancy > 3 months
- •- Patient affiliate to french social secutity
- •- Laboratory criteria:
- •SGPT and SGOT < 5 fold the upper normal value
- •Kaliemia > 3 mM
- •- Patients receiving ABI 1000 mg/day through step 1 for at least two months
- •- At least two measures of ABI plasma concentrations available within the first three months of treatment
- •- Mean of ABI concentration < 8,5ng/mL.
- •- Progressive disease according to PCWG3 criteria within 28 weeks following starting of ABI in the step 1 (according to PCWG3 criteria of progression at trial entry, isolated PSA increase will be accepted).
- •- Inclusion in step 2 must occur within 2 months following the first observation of cancer progression while in step 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pure small cell carcinoma of the prostate or predominant histology of neuro-endocrine carcinoma
- •- Confirmed brain and/or leptomeningeal metastases
- •- Previous treatment with docetaxel or any other anticancer treatment for castration-resistant prostate carcinoma (previous docetaxel for hormone-sensitive metastatic disease is allowed)
- •- Previous treatment with ABI or any other 17 B hydroxylase inhibitor or Enzalutamide
- •-Treatment with first-generation antiandrogen performed on the day of screening or within previous four weeks.
- •- Patient co-morbidities:
- •Galactose hypersensitivity, Lapp lactase deficiency.
- •Cirrhosis Child-Pugh B or C
- •Active or symptomatic viral hepatitis
- •Heart failure stage NYHA III or IV
- •Cardiac arythmia, heart failure stage NYHA II, ischemic cardiopathy or uncontroled hypertension, except if left ventricular ejection fraction is > 50%
- •Patients with left ventricular ejection fraction (LVEF) < 50%
- •Severe hypokaliema
- •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
- •Prior or concurrent malignant disease in complete remission for less than 3 years, except T1N0 vocal cord carcinoma, basal or squamous cell skin carcinoma and in situ transitional cell bladder carcinoma
- •- Limitation of the patient's ability to comply with the treatment or to follow the protocol.
- •- Persistent grade 3-4 toxicities related to ABI. In case of persistent grade 2 toxicity or resolutive grade 3-4 toxicities, inclusion in step 2 must be discussed in a case by case basis with the study coordinating Investigator.
- •- All non-inclusion criteria for step 1 apply
- •- Patient who does not take ABI daily at the investigator opinion
研究者
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