Phase 1b exploratory study of [18F]AH111585-PET as a marker of angiogenic response to combination therapy with the pan-VEGF inhibitor, pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer

Imperial College London (UK)0 个研究点目标入组 17 人开始时间: 2011年8月10日最近更新: 2019年4月8日

适应症

试验速览

暂无简介。

•1. Age over 18 years
•2. Diagnosis of relapsed ovarian cancer
•3. Responded to at least on one line of prior platinum based therapy
•4. Relapsed within platinum resistant interval (=6months)
•5. Eastern Cooperative Oncology Group (ECOG) performance status of <2
•6. Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter = 25mm using conventional techniques
•7. Adequate organ system function
•8. Female participants only

•1. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90mmHg].
•Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.
•2. Treatment with any of the following anti-cancer therapies:
•2.1. Radiation therapy 28 days prior to the first dose of pazopanib OR
•2.2. Surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
•2.3. Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
•3. Treatment with anti-angiogenic therapy
•4. Presence of gross ascites
•5. Clinically significant peripheral neuropathy
•6. Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

发起方

Imperial College London (UK)