- A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery — Recruiting • Phase II • Oncology • NCT06504147.
- Sponsor: Oncoinvent Solutions AS.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must…
- : 1. Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP). 2. Female of age ≥ 18 years. 3. Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C or IV). 4. Peritoneal and other metastases eligible for IDS to no residual tumour. 5. Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy. 6. Confirmed HR proficient tumour. 7. Received NACT (numbers of cycles as per investigator's discretion) with regress or stable disease on diagnostic imaging and assessed to be operable to R0 pre-surgery. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 2 and patient fit enough to undergo IDS and further treatment according to standard of care. 9. Adequate renal function: • Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min. 10. Adequate hepatic function: * Serum bilirubin < 1.5 x upper limit of normal (ULN), and * Aspartate transaminase and alanine transaminase ≤ 3 x ULN. 11. Adequate bone marrow function: * Absolute neutrophil count ≥…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.