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NCT06504147 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Ovarian Cancer and Peritoneal Carcinomatosis, sponsored by Oncoinvent Solutions AS.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 10
- Study locations
NCT06504147 is a Phase 2 study of Ovarian Cancer and Peritoneal Carcinomatosis that is actively recruiting participants, run by Oncoinvent Solutions AS. The registered enrollment target is 114 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (84% lower). The trial reports 10 study locations across 2 states.
The verdict
NCT06504147, a Phase 2 study of Ovarian Cancer and Peritoneal Carcinomatosis, is actively recruiting participants, sponsored by Oncoinvent Solutions AS.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 10
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Radspherin
Study Locations (10)
Other
- UZ Leuven - Leuven
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma
- The Norwegian Radiumhospital - Oslo
- Hospital Universitari de Bellvitge - Barcelona
- Clinica Universidad de Navarra - Madrid
- Clinica Universidad de Navarra - Pamplona
- Hospital Universitari i Politècnic La Fe - Valencia
- Imperial College Healthcare NHS Trust - London
- University Hospital Southampton NHS Foundation Trust - Southampton
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2024-06-15 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06504147
The ClinicalTrials.gov registry entry for NCT06504147 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Oncoinvent Solutions AS, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which Radspherin is the first listed.
NCT06504147 reports 10 study locations spanning 2 distinct geographic areas - top geographies include Other, Florida.
Frequently Asked Questions
What is clinical trial NCT06504147 about?
NCT06504147 is a clinical study titled "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". 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,...
What is the current status of trial NCT06504147?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2024-06-15. Estimated completion is 2031-02-28.
What conditions does trial NCT06504147 study?
This clinical trial studies the following conditions: Ovarian Cancer, Peritoneal Carcinomatosis.
What interventions are being tested in trial NCT06504147?
The interventions under investigation include: Radspherin (DRUG).
Who is sponsoring clinical trial NCT06504147?
This trial is sponsored by Oncoinvent Solutions AS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06504147 being conducted?
This trial has 10 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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