Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to Niraparib in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With Niraparib (REVOCAN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04826198|
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: AsiDNA Drug: Niraparib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicenter, open label, phase Ib/II|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicentric, Phase Ib/II Study to Assess the Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to Niraparib in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With Niraparib Since at Least 6 Months|
|Actual Study Start Date :||October 5, 2020|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2023|
Experimental: AsiDNA in addition to Niraparib
Part A: AsiDN in addition to Niraparib (Safety evaluation) Part B: AsiDN in addition to Niraparib (Efficacy evaluation and Safety confirmation )
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
- Dose limiting toxicities (DLT) [ Time Frame: 21 days ]
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:
- Grade 4 neutropenia lasting ≥ 7 days,
- Febrile Neutropenia,
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826198
|Contact: Patricia PAUTIER, MD||0142114211 ext +firstname.lastname@example.org|
|Contact: Thibaud MOTREFF||0142114211 ext +email@example.com|