drugset / Trial / NCT04826198

Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months

NCT04826198

Phase 1/2 Terminated 13 enrolled Gustave Roussy, Cancer Campus, Grand Paris
NaSingle-groupOpen-labelTreatment

Summary

The objective of REVOCAN study is to assess the abrogation of PARP inhibitors resistance in patients with relapsed platinum sensitive ovarian cancer treated with PARP inhibitors in maintenance since at least 6 months and who have only an increase of CA 125 without any progression according to RECIST criteria. AsiDNATM at 600 mg will be tested in addition to PARP inhibitors given according to the label in REVOCAN study.

Timeline

Start
2020-10-05
Primary completion
2024-04-04
Completion
2024-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject AsiDNA Oligonucleotide (other) 100 mg Intravenous
Background Niraparib Small molecule 100 mg Oral
Background Niraparib Small molecule 200 mg Oral
Background Niraparib Small molecule 300 mg Oral
Background Olaparib Small molecule 400 mg Oral
Background Olaparib Small molecule 500 mg Oral
Background Olaparib Small molecule 600 mg Oral
Background Rucaparib Small molecule 600 mg Oral
Background Rucaparib Small molecule 800 mg Oral
Background Rucaparib Small molecule 1000 mg Oral
Background Rucaparib Small molecule 1200 mg Oral

Indications