Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06504147
PHASE2

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

Sponsor: Oncoinvent Solutions AS

View on ClinicalTrials.gov

Summary

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 be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.

Official title: A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2024-06-15

Completion Date

2031-02-28

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

Radspherin

Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension. 224Ra has a physical half-life of 3.6 days.

Locations (10)

Moffitt Cancer Center

Tampa, Florida, United States

UZ Leuven

Leuven, Belgium

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

The Norwegian Radiumhospital

Oslo, Norway

Hospital Universitari de Bellvitge

Barcelona, Spain

Clinica Universidad de Navarra

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Imperial College Healthcare NHS Trust

London, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom