Cancer patients whose disease has undergone clinical progression while receiving treatment or following treatment with a PARPi for an approved indication. Cancer
Conditions
Interventions
Each patient must participate in the informed consent process and sign and date an informed consent form (ICF) for this protocol before any protocol-required procedures are performed. Participants wil
Sponsors
Artios Pharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. DNA extracted from tumour samples will be analysed by Whole Exome Sequencing (WES) for copy number variations (CNV), as well as gene fusions, single nucleotide variations (SNVs) and insertions and deletions (indels). 2. ctDNA extracted from whole blood will be analysed for CNV, as well as gene fusions, SNVs and indels by Next Generation Sequencing (NGS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/02/2024: 1. Tumour samples will be analysed by ribonucleic acid (RNA) sequencing (RNASeq), immunohistochemistry (IHC), or other suitable methods which can be used to assess transcriptomic or proteomic alterations. 2. The incidence and nature of transcriptomic or proteomic alterations will be assessed. 3. ctDNA: Assessment of DNA sequence analysis to determine the incidence of BRCA1 and BRCA2 reversions. Previous secondary outcome measures: 1. Tumour samples will be analysed by ribonucleic acid (RNA) sequencing (RNASeq), RNAscope, immunohistochemistry (IHC), or other suitable methods which can be used to assess transcriptomic or proteomic alterations. 2. The incidence and nature of transcriptomic or proteomic alterations will be assessed. 3. ctDNA: Assessment of DNA sequence analysis to determine the incidence of BRCA1 and BRCA2 reversions. | — |
Countries
England, United Kingdom
Contacts
Public ContactSophie Brenner
Outcome results
None listed