NCT03074032已完成1 期
Phase I Open-label Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Avionco LLC2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- DLT within 4 weeks of ONC1-0013B administration (safety and tolerability)
研究概览
简要总结
This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA values will be evaluated during the study as an additional point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 years and older.
- •Histologically confirmed diagnosis of prostate cancer
- •Castrate level of testosterone in blood serum < 1,7 nmol/l or < 50 ng/dl
- •PSA level at screening > 2 ng/ml
- •Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy.
- •The patient's ECOG performance status of 0 - 2
- •Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC
- •The expected survival time of not less than 12 weeks
排除标准
- •Prior anticancer therapy:
- •Treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ II grade according to CTCAE scale, related to prior anticancer therapy (excluding alopecia)
- •Prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening
- •Exposure to bisphosphonates is allowed only if the treatment started prior to screening
- •Clinically significant cardiovascular system diseases:
- •Clinically significant central nervous system diseases:
- •History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)
- •Prior or concomitant therapy:
- •Exposure to drugs which may cause a convulsive state within 4 weeks prior to screening
- •Exposure to treatment with characteristics of CYP3A4 or CYP2D6 inhibitors within 4 weeks prior to screening
- •Exposure to treatment relating to the Class I risk of QT-interval prolongation; exposure to treatment relating to the Class II risk of QT-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment
研究组 & 干预措施
ONC1-0013B 320 mg
Experimental
ONC1-0013B 320 mg per os daily
干预措施: ONC1-0013B (Drug)
ONC1-0013B 40 mg
Experimental
ONC1-0013B 40 mg per os daily
干预措施: ONC1-0013B (Drug)
ONC1-0013B 80 mg
Experimental
ONC1-0013B 80 mg per os daily
干预措施: ONC1-0013B (Drug)
ONC1-0013B 160 mg
Experimental
ONC1-0013B 160 mg per os daily
干预措施: ONC1-0013B (Drug)
结局指标
主要结局
DLT within 4 weeks of ONC1-0013B administration (safety and tolerability)
时间窗: 4 weeks and during the study up to 76 weeks
Incidence rate and severity of adverse events, changes in laboratory tests
次要结局
- Area under the plasma concentration versus time curve (AUC)(28 days)
- Elimination half-life (T1/2)(28 days)
- Time-to-peak concentration (tmax)(28 days)
- Tumor response(12 weeks and during the study up to 76 weeks)
- Peak Plasma Concentration (Cmax)(28 days)
- Steady-State Concentration (Css)(28 days)
研究者
研究点 (2)
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