ClinicaliQ Trial Snapshot
- 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.
- What is being tested: Radspherin® (a single intraperitoneal injection) is being evaluated for efficacy and safety in patients with primary advanced high-grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with peritoneal metastasis who are homologous recombination….
- Patient eligibility overview: The trial targets patients with advanced epithelial cancers with peritoneal spread that are HR-proficient (excluding HR-deficient cases typically treated with PARP inhibitors), who are fit for chemotherapy and surgical intervention as part of standard treatment pathways.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : 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.