Tissue and blood collection study from patients who have progressed on a PARP inhibitor (a type of targeted cancer drug)

Not Applicable

• Conditions: Cancer patients whose disease has undergone clinical progression while receiving treatment or following treatment with a PARPi for an approved indication.; Cancer

• Registration Number: ISRCTN45249890
• Lead Sponsor: Artios Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-07
• Last Update Posted: 18 March 2024
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified