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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Unit dose: Vial containing 100 mg of AsiDNA™ (free acid) Regimen: 3 consecutive infusions (D1, D2, D3) followed by a once a week iv infusion on D8 and D15 of a 21 day-treatment cycle at first cycle, then weekly iv infusion in the absence of disease progression or unacceptable toxicity Mode/route: 1 hour intravenous (iv) infusion
Unit dose: Hard capsule containing 100mg of Niraparib Regimen: The last dose given during the 6 previous months of Niraparib 200 mg/day or 300 mg/day, (or 100 mg/day only if the patient has received this dose since at least 6 months) Daily, 1, 2 or 3 hard capsules at 100mg once daily at approximately the same time each day. Mode/route: Per os
Product name: Olaparib Pharmaceutical form: Tablets containing 100 or 150mg of Olaparib Route of administration: per os Dose Regimen: The last dose given during the 6 previous months of Olaparib 600 mg/day or 500 mg/day, (or 400 mg/day only if the patient has received this dose since at least 6 months) Two times daily (300mg or 250 mg or 200mg) at approximately the same time each day.
Product name: Rucaparib Pharmaceutical form: Tablets containing 200 or 250 or 300mg of Rucaparib Route of administration: per os Dose Regimen: The last dose given during the 6 previous months of Rucaparib 1200 mg/day or 1000 mg/day, or 800mg/day (or 600 mg/day only if the patient has received this dose since at least 6 months) Two times daily (600mg or 500mg or 400mg or 300mg) at approximately the same time each day.
CHU Jean Minjoz
Besançon, Besancon, France
Hospices civils de Lyon(CHU Lyon Sud)
Pierre-Bénite, Lyon, France
Institut de Cancérologie de l'Ouest - St Herblain
Saint-Herblain, Nantes, France
Gustave Roussy
Villejuif, Val De Marne, France
Institut Bergonié
Bordeaux, France
Centre Antoine Lacassagne
Nice, France
Dose limiting toxicities (DLT)
Occurrence of cases of Dose Limiting Toxicity (DLT) will be recorded and reviewed according to a predefined definition. DLTs include the following specific treatment-related AEs occurring during the first 21 days (from D1 to D21) treatment period (based on the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events (AE) \[CTCAE\] scale, version 5.0 defined as: * Haematological toxicity: 1. Grade 4 neutropenia lasting ≥ 7 days, 2. Febrile Neutropenia, 3. Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding. * Non haematological toxicity: Any drug-related non-hematological toxicity grade ≥ 3 toxicity (except alopecia, fatigue, nausea, controlled hypertension and vomiting adequately treated with antiemetic treatment and non-clinically significant laboratory values abnormalities).
Time frame: 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.