Gynecologic oncology · 2025
First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer.
СтатьяКлиническое исследование I фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Wang Yun, Van Nieuwenhuysen Els, Revheim Mona-Elisabeth, Deroose Christophe M, Eriksson Ane Gerda Zahl, Eyjolfsdottir Brynhildur, Van Gorp Toon, Baert Thaïs, Aksnes Anne-Kirsti, Myren Kari, Vergote Ignace, Bruland Øyvind S
Аннотация
OBJECTIVE: The aim of this Phase 1 study was to evaluate safety and tolerability of the alpha emitting therapy 224Ra-labeled microparticles (Radspherin®) and to establish the recommended dose for further development.
METHODS: The study was conducted in patients who had undergone complete resection of platinum-sensitive recurrent ovarian cancer. A single dose of Radspherin was administered intraperitoneally one to three days after surgery. Dose escalation (3 + 3 design) was performed at 1, 2, 4 and 7 MBq. Safety and tolerability of Radspherin after 12 months are presented.
RESULTS: Fourteen patients were enrolled across the 4 dose levels. Median age was 66 (56-77) years. Median peritoneal cancer index at the start of the surgery was 7 (3-16). No dose limiting toxicity (DLT) was observed. A total of 98 treatment emergent adverse events were reported (95 grade 1 or 2, and 3 grade 3). The three grade 3 events were cases of ileus (2) and anaemia (1) and were reported as unrelated to Radspherin by the investigators. One grade 2 serious adverse event of procedural complication (disconnect syringe-catheter) was reported as related to Radspherin. At 12-months, none of the patients had experienced peritoneal disease progression.
CONCLUSIONS: All dose levels were well tolerated, with no DLT observed. The highest activity dose of 7 MBq was selected as recommended dose for an expansion cohort. No grade ≥ 3 adverse events related to Radspherin were reported.
CLINICAL TRIAL INFORMATION: NCT03732768.
METHODS: The study was conducted in patients who had undergone complete resection of platinum-sensitive recurrent ovarian cancer. A single dose of Radspherin was administered intraperitoneally one to three days after surgery. Dose escalation (3 + 3 design) was performed at 1, 2, 4 and 7 MBq. Safety and tolerability of Radspherin after 12 months are presented.
RESULTS: Fourteen patients were enrolled across the 4 dose levels. Median age was 66 (56-77) years. Median peritoneal cancer index at the start of the surgery was 7 (3-16). No dose limiting toxicity (DLT) was observed. A total of 98 treatment emergent adverse events were reported (95 grade 1 or 2, and 3 grade 3). The three grade 3 events were cases of ileus (2) and anaemia (1) and were reported as unrelated to Radspherin by the investigators. One grade 2 serious adverse event of procedural complication (disconnect syringe-catheter) was reported as related to Radspherin. At 12-months, none of the patients had experienced peritoneal disease progression.
CONCLUSIONS: All dose levels were well tolerated, with no DLT observed. The highest activity dose of 7 MBq was selected as recommended dose for an expansion cohort. No grade ≥ 3 adverse events related to Radspherin were reported.
CLINICAL TRIAL INFORMATION: NCT03732768.