jRCT2031230184进行中（未招募）不适用
A Phase I Dose Escalation And Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 267
- 主要终点
- Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts:
- •Japan cohort
- •Castration resistant prostate cancer that is resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3)
- •Other inclusion criteria:
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or
- •Adequate organ function
排除标准
- •Prior Chemotherapy: no more than 2 previous regimens of chemotherapy
- •Prior irradiation to >25% of the bone marrow.
- •QTcF interval >480 msec at screening.
- •Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
- •Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)
- •Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
- •Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers or inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational product.
结局指标
主要结局
Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
时间窗: Baseline up to 90 days
First cycle DLTs will be utilized to determine the MTD
Overall safety profile including adverse events
时间窗: Baseline up to approximately 2 years
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [4.03])
Overall safety profile including laboratory abnormalities
时间窗: Baseline up to approximately 2 years
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version [4.03]), and timing.
Preliminary efficacy determination as evaluated by disease specific response criteria
时间窗: Through study completion, approximately 2 years past last patient first visit.
Objective response using Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC).
Overall safety profile including vital signs
时间窗: Baseline up to approximately 2 years
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.
次要结局
- progression-free survival (PFS)(Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.)
- PSA50(Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.)
- Duration of Response (DoR)(Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.)
- Time to first skeletal related event(Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.)
- Time to symptomatic skeletal related event(Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.)
- overall survival(Baseline up to approximately 2 years)
- Maximum Observed Plasma Concentration (Cmax)(At specific timepoints from Cycle 1 day 1 to End of Treatment visit)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(At specific timepoints from Cycle 1 day 1 to End of Treatment visit)
- Area Under the Curve (AUC)(At specific timepoints from Cycle 1 day 1 to End of Treatment visit)
- Apparent Oral Clearance (CL/F)(At specific timepoints from Cycle 1 day 1 to End of Treatment visit)
- Apparent Volume of Distribution (Vz/F)(At specific timepoints from Cycle 1 day 1 to End of Treatment visit)
- Plasma Decay Half-Life (t1/2)(At specific timepoints from Cycle 1 day 1 to End of Treatment visit)
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