A phase II trial evaluating the activity of cabozantinib in pre-treated patients with metastatic colorectal cancer (mCRC). - ABACO trial

Dipartimento di Medicina di Precisione - Università degli studi della Campania L. Vanvitelli0 个研究点目标入组 33 人开始时间: 2021年5月24日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•1. Histologically proven diagnosis of colorectal adenocarcinoma.
•2. Male or female patients = 18 years of age.
•3. Diagnosis of metastatic disease.
•4. Known RAS status (NRAS and KRAS exon 2,3 and 4) per local
•laboratory assessment.
•5. Patients should have received at least two standard lines of treatment including all the following: fluoropyrimidines, irinotecan, oxaliplatin, anti-angiogenic drugs (eg. bevacizumab and or aflibercept) and, in case of patients harbouring RAS WT tumours, anti-Epidermal Growth Factor receptors monoclonal antibodies (cetuximab or panitumumab). Note:
•Prior treatment with trifluridine-tipiracil is allowed.
•6. Recovery to baseline or = Grade 1 CTCAE v.5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
•7. Measurable disease according to RECIST criteria v1.1.
•8. ECOG Performance Status 0-1.
•9. Life expectancy of at least 3 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 33
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 33

•1. Prior treatment with cabozantinib.
•2. Prior treatment with VEGFR-targeting TKI (e.g. regorafenib).
•3. Treatment with any anticancer drug within 4 weeks before study entry.
•4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before study entry. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
•5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before study entry. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of study entry.

发起方

Dipartimento di Medicina di Precisione - Università degli studi della Campania L. Vanvitelli