NL-OMON54399招募中4 期
Pharmacokinetic boosting of olaparib to improve exposure, tolerance and cost-effectiveness (PROACTIVE-study) - PROACTIVE
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Part A - proof of concept
- •Subjects who start or are on treatment with olaparib tablets, according to
- •the drug label and physician*s discretion;
- •Subjects who are able and willing to provide written informed consent prior
- •to screening;
- •Age of 18 years or older;
- •Able to measure the outcome of the study in this subject (e.g. patient
- •availability; willing and being able to undergo repeated plasma sample
- •collection);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •Part B - clinical evaluation
- •Subjects who start on treatment with olaparib tablets, according to the drug
- •label and physician*s discretion;
- •Subjects who are able and willing to provide written informed consent prior
- •to screening;
- •Age of 18 years or older;
- •Able to measure the outcome of the study in this subject (e.g. patient
- •availability; willing and being able to undergo sample collection for PK and PD
- •Expected to be on olaparib treatment for >= 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
排除标准
- •Part A + B
- •Concurrent use of other anti-cancer therapies;
- •Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with
- •the KNMP *G-standaard*;
- •Known contra-indications for treatment with cobicistat in line with the
- •summary of product characteristics;
研究者
相似试验
进行中（未招募）
1 期
A lower dose olaparib (Lynparza®), combined with a drug which inhibits olaparib degradation, to increase tolerability and decrease the price of the treatment with olaparibMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Ovarian cancerEUCTR2021-004032-28-NLRadboud University Medical Center160
招募中
4 期
Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectivenessCancerNCT05078671Radboud University Medical Center160
已完成
不适用
Olaparib dose escalation in combination with high dose radiotherapy to the breast and regional lymph nodes in patients with breast cancermetastatic breast cancer10006291breast cancerNL-OMON44691ederlands Kanker Instituut72
进行中（未招募）
1 期
Olaparib in combination with pembrolizumab in HRRm and HRD positive cancerEUCTR2019-001745-40-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.300
进行中（未招募）
1 期
Olaparib in combination with pembrolizumab in HRRm and HRD positive cancerEUCTR2019-001745-40-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.300