EUCTR2016-004429-17-NO进行中（未招募）1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL TESTING IPATASERTIB PLUS ABIRATERONE PLUS PREDNISONE/PREDNISOLONE, RELATIVE TO PLACEBO PLUS ABIRATERONE PLUS PREDNISONE/PREDNISOLONE IN ADULT MALE PATIENTS WITH ASYMPTOMATIC OR MILDLY SYMPTOMATIC, PREVIOUSLY UNTREATED, METASTATIC CASTRATE-RESISTANT PROSTATE CANCER
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,101
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •- Aged >= 18 years
- •- Eastern Cooperative Oncology Group performance status of 0 or 1
- •- Adequate hematologic and organ function test results within 28 days before the first study treatment
- •- Life expectancy of at least 6 months
- •- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in the protocol
- •- For enrollment into the China extension cohort, residence in the People's Republic of China
- •Disease-Specific Inclusion Criteria:
- •- Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
- •- Consent to provide a formalin-fixed, paraffin-embedded tissue block or a minimum of 15 freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report
- •- A valid PTEN IHC result
- •- Metastatic disease documented prior to randomization by clear evidence of bone lesions by bone scan and/or measurable soft tissue disease by computed tomography (CT) and/ or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors, Version 1.1(RECIST v1.1)
- •- Asymptomatic or mildly symptomatic form of prostate cancer
- •- Progressive disease before initiating study treatment, defined using at least one of the following criteria:
- •. Two rising prostate-specific antigen (PSA) levels measured >= 1 week apart with second result >= 1 ng/mL according to Prostate Cancer Working Group 3 (PCWG3) criteria (Patients who have received an anti-androgen therapy must have PSA progression after withdrawal [>= 4 weeks since last flutamide or >= 6 weeks since last treatment of bicalutamide or nilutamide])
- •. Radiographic evidence of disease progression in soft tissue according to RECIST v1.1 and/or bone scan according to PCWG3 criteria
- •- Ongoing androgen deprivation with gonadotropin-releasing hormone analog or bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 2.0 nmol/L) within 28 days before randomization
- •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 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 825
排除标准
- •-Inability or unwillingness to swallow whole pills
- •-History of malabsorption syndrome/other condition that would interfere with enteral absorption
- •-Clinically significant history of liver disease consistent with Child-Pugh Class B or C including cirrhosis, current alcohol abuse or current known active infection with hepatitis B or B virus
- •.Patients positive for anti-HBc are eligible only if test results are negative for HBsAg and polymerase chain reaction is negative for HBV DNA
- •.Patients positive for HCV serology are eligible only if testing for HCV RNA is negative
- •-Need of more than 10 mg/day of prednisone or equivalent dose of other anti-inflammatory corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease
- •-Active infection requiring intravenous antibiotics within 14 days before Day1 Cycle 1 (D1 C1)
- •-History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- •-History of another malignancy within 5 years prior to randomization except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of bladder or other malignancies where patient has undergone potentially curative therapy with no evidence of disease and are deemed by treating physician to have a recurrence rate of <5% at 5 years
- •-Any other diseases, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that may affect interpretation of results or renders patients at high risk from treatment complications
- •Disease-Specific Exclusion Criteria
- •-Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate
- •-Any therapy including chemotherapy or biological therapy for treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-a reductase inhibitor is permitted
- •-In setting of chemotherapy received for hormone-sensitive prostate cancer, treatment with chemotherapy initiated more than 6 months after time of first castration. Patients should not have progressed during/within 3 months after completion of chemotherapy-based treatment
- •-Use of opioid medication for cancer-related pain including codeine and dextropropoxyphene currently or any time within 4 weeks of D1 C1
- •-Prior treatment with abiraterone/other known potent CYP17 inhibitors or investigational agents that block androgen synthesis. Prior treatment with itraconazole and fluconazole is permitted
- •-Prior treatment with enzalutamide/other potent androgen-receptor blockers approved or experimental
- •-Prior treatment with flutamide, steroidal anti-androgens, androgens or estrogens treatment within 4 weeks of C1 D1
- •-Prior treatment with bicalutamide/nilutamide within 6 weeks of C1 D1
- •-Prior treatment with 5a reductase inhibitors within 4 weeks of C1 D1
- •-Prior treatment with systemic radiopharmaceuticals (except for imaging). Focal palliative radiation to treat cancer-related pain is permitted provided that last treatment with radiation is at least 14 days prior to C1 D1
- •-Prior treatment with approved or experimental therapeutic agents with known inhibition of PI3K pathway, including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors
- •-Administration of investigational therapeutic agent within 28 days of C1 D1
- •-Known untreated or a
研究者
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