Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progre
The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with oligometastatic progression (OMP) after first maintenance therapy with any PARP inhibitor. A total of 30
| Condition(s) | Ovarian Cancer, Oligometastatic Disease, Serous Ovarian Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with oligometastatic progression (OMP) after first maintenance therapy with any PARP inhibitor. A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg, according to body weight or platelet count. Patients will start treatment within 8 weeks after surgery and will receive it until progressive disease or treatment discontinuation. The main purpose of the study is to evaluate progression-free survival (PFS) of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery. |
| Who can participate | Inclusion Criteria: 1. Written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female patients ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Patients must have a life expectancy ≥16 weeks. 5. Histologically confirmed high grade serous or endometrioid OC who have an OMP during or after the first maintenance therapy with any PARPi. 6. Oligometastatic progression defined as 1-5 lesions (according to European Society for Radiotherapy and Oncology \[ESTRO\] and American Society for Radiation Oncology \[ASTRO\] consensus). Note: Metastatic lymph nodes located within the same anatomical lymph-node chain or station, as confirmed on surgical specimen, shall be counted collectively as one single metastatic lesion. 7. Pat |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | MedSIR |
| Locations | A Coruña, Spain; Barakaldo, Spain; Barcelona, Spain; Girona, Spain; Jaén, Spain; Madrid, Spain (+8 more sites) |
| Start date | 2024-12-03 |
| NCT ID | NCT06180356 |
| Official listing | https://clinicaltrials.gov/study/NCT06180356 |