EUCTR2016-004429-17-PT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
适应症
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 clinical trial of medicinal product
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 or 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 HBV or HCV. Patients who are positive for anti-HBc are eligible only if test results are also positive for HbsAg and polymerase chain reaction is negative for HBV DNA. Patients who are 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 D1C1
- •- 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 nonmuscle-invasive urothelial carcinoma of the bladder or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the 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 the use of an investigational drug or that may affect the interpretation of the results or renders the 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 the treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-¿ reductase inhibitor is permitted
- •- In the setting of chemotherapy received for hormone-sensitive prostate cancer, treatment with chemotherapy initiated more than 6 months after time of first castration (i.e., delayed initiation of chemotherapy for HSPC). Patients should not have progressed during or within 3 months after the completion of chemotherapy-based treatment (i.e. rapid progression on chemotherapy for HSPC).
- •- Use of opioid medication for cancer-related pain, including codeine and dextropropoxyphene, currently or any time within 4w of D1C1,- 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 4w of C1D1, - Prior treatment with bicalutamide/nilutamide within 6w of C1D1, - Prior treatment with 5¿ reductase inhibitors within 4w of C1D1, - Prior treatment with systemic radiopharmaceuticals (except for imaging). Focal palliative radiation to treat cancer-related pain is permitted provided that the last treatment with radiation is at least 14 days prior to C1D1
- •- Prior treatment with approved or experimental therapeutic agents with known inhibition of the PI3K pathw
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