A study to investigate the type and frequency of molecular alterations in the cancers of patients whose disease has undergone clinical progression while receiving treatment or following treatment with a PARP inhibitor for an approved indication.

Artios Pharma Limited0 个研究点目标入组 20 人开始时间: 2022年12月7日最近更新: 2024年3月18日

适应症

试验速览

暂无简介。

•1. Provide signed written informed consent for this study (Cohort 1). Patients with archival tissue who are not able to provide a new biopsy (Cohort 2) or deceased patients (Cohort 3) must have provided generic research consent for use of clinical data and tissue/blood samples.
•2. =18 years of age.
•3. Histologically- or cytologically-confirmed diagnosis of cancer.
•4. Have cancer that has undergone disease progression while receiving treatment or following treatment with a PARPi for an approved indication or within a clinical trial. (Note at the discretion of the Sponsor patients may have received a subsequent treatment following disease progression during or following treatment with a PARPi). Patients may have received PARPi treatment in combination with another treatment.
•For Cohort 1 only:
•5. Willing to provide either a core biopsy from a tumour lesion that has exhibited progression on or after PARPi treatment and that is deemed suitable for imaging-guided biopsy (ultrasound or computed tomography [CT]) by an experienced radiologist or suitable for intra-operative biopsy during secondary debulking surgery as determined by an experienced oncology surgeon and a blood sample for WES, and/or a blood sample for ctDNA analysis.

•1. Discontinued PARPi for toxicity within 2 months of starting PARPi.
•For Cohort 1 only:
•2. For patients requiring a new biopsy, have a significant bleeding disorder or coagulopathy that in the investigator’s opinion would increase the risk associated with study biopsy.
•3. Any other severe concurrent disease which may increase the risk associated with study participation.
•4. Any psychological, familiar, sociological or geographical considerations potentially hampering compliance with the study and follow up schedule.

发起方

Artios Pharma Limited