PARPi 2X-121 in Ovarian Cancer
Research type
Research Study
Full title
Phase 2, prospective open label, single arm study to investigate anti-tumor effect and tolerability of 2X-121 in patients with advanced ovarian cancer selected by the 2X-121 DRP®.
IRAS ID
282261
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Oncology Venture A/S
Eudract number
2020-000539-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
137047, IND (FDA); SMR-3784, CRO
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
The study aims to evaluate if patients (who have relapsed from 2 or more lines of chemotherapy) selected by analysis of their individual ovarian tumour can demonstrate an improved response to 2X-121 (a PARP Inhibitor) compared to historical data from the literature which shows decreasing response rates with the number of treatment lines. PARP inhibitors, have shown effects in a subgroup of patients with OC. The method for selecting the patients (DRP method) sensitive to 2X-121 has previously been used in a phase 1 study to identify responding patients.
The study will include patients with OC, who have progressed after at least two lines of treatment, and after screening of their tumour about half of the patients will be offered participation in this clinical trial. The patients will be treated at experienced oncology sites in US and UK. The patients will receive 2X-121 capsules daily in a 28-day schedule and continue until disease progression or inacceptable toxicity. From previous treated patients the adverse events have been manageable and have included fatigue and gastrointestinal symptoms. The response and adverse events will be closely monitored in this study.
If successful the study can lead to pivotal study of patients, who will have a high likelihood for responding to the drug and therefore a tool for personalized treatment.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0282
Date of REC Opinion
7 Jan 2021
REC opinion
Further Information Favourable Opinion