ACTRN12616000983404已完成1 期
An Open-label, Pilot Pharmacokinetic Study to Determine the Bioavailability, Safety, and Tolerability of a Single Dose of Oradoxel in Metastatic Prostate Cancer Patients Treated With Intravenous Docetaxel
Kinex Pharmaceuticals Inc0 个研究点目标入组 11 人开始时间: 2016年7月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
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-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Eligible participants must be males at least 18 years of age with metastatic prostate cancer who are scheduled to receive their prescribed dose of treatment with IV docetaxel. Patients may be receiving steroid treatment or ADT for prostate cancer, but other concomitant cancer chemotherapy is not permitted.
- •They must have:
- •- adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF);
- •- Adequate liver function as demonstrated by: Total bilirubin of less than the upper limit of normal (ULN); Aspartate transaminase (AST) and alanine aminotransferase (ALT) less than/equal to 1.5 times ULN; Alkaline phosphatase (ALP) less than/equal to 2.5 times ULN or less than 5 times ULN if bone metastases are present
- •- Adequate renal function as demonstrated by serum creatinine less than/equal to 177 micromole/L or creatinine clearance greater than 60 mL/min as calculated by the Cockcroft and Gault formula
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy of at least 6 months; Willing to fast for 8 hours before and 4 hours after Oradoxel administration; Willing to abstain from alcohol consumption from 3 days prior Study Period 1 through to the Final Visit; Willing to refrain from caffeine consumption for 12 hours prior to each dose of study drug through the completion of protocol-specified PK sampling time-points; Sexually active participants must use a barrier method of contraception during the study and agree to continue the use of contraception for at least 30 days after the last dose of study drug.
排除标准
- •Eligible participants must not be
- •- currently taking a prohibited concomitant medication;
- •- have unresolved toxicity from prior chemotherapy (participants must have recovered from all significant toxicity to less than or equal to Grade 1 CTCAE toxicity from previous anticancer treatments or previous investigational agents);
- •- planning to receive other medical, surgical, or radiological treatments for prostate cancer during the course of this study;
- •- received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer;
- •- uncontrolled intercurrent illness; no major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption;
- •- known history of allergy to docetaxel, Cremophor (Registered Trademark), or polysorbate 80 (Tween 80);
- •- any other condition which the Investigator believes would make participation in the study not acceptable.
研究者
相似试验
已完成
不适用
A study of Budesonide Tablets 9mg in Healthy Indian Subjects under Fasting Condition.CTRI/2019/08/021011Dr Uday Harle24
进行中（未招募）
1 期
A Phase I randomized, open-label pharmacokinetic comparability study comparing pre- and post-change teclistamab in participants with relapsed/refractory multiple myelomaRelapsed/refractory multiple myelomaCancerISRCTN46766641Janssen-Cilag International NV100
进行中（未招募）
1 期
Drug metabolism related to obesityMedDRA version: 19.1Level: LLTClassification code 10029885Term: Obesity, unspecifiedSystem Organ Class: 100000004861EUCTR2014-004554-34-DKBispebjerg Hospital
进行中（未招募）
1 期
Clinical Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric ParticipantsPediatric psoriasis(PsO)Juvenile psoriatic arthritis (jPsA)MedDRA version: 20.0Level: PTClassification code 10076674Term: Juvenile psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2021-005085-18-Outside-EU/EEAJanssen Research & Development, LLC
进行中（未招募）
1 期
Feramyl® PK and safety trial in patients suffering from anaemia following cardiac surgeryEUCTR2015-003069-28-DKSerumwerk Bernburg AG32