Trial Type
Follow-Up Treatment (Metastatic Disease)
Description for experts
A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Description for laymen
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
JSON Data
{
"short_title": "RAMP 301",
"data_mode": "900",
"data_mode_number": "000002428",
"official_title": "A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "neoadjuvant",
"therapielinie_value": "gtThird",
"ctgov_number": "NCT06072781",
"eudract_number": null,
"general_contact_email": "studiensekretariat.gyn@ukdd.de",
"general_contact_phone": "+49 351-4584202",
"hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger",
"description_laie_de": "In dieser Studie werden die Sicherheit und Wirksamkeit von Avutometinib (VS-6766) in Kombination mit Defactinib im Vergleich zu den vom Pr\u00fcfer gew\u00e4hlten Behandlungsmethoden (ICT) bei Patienten mit rezidivierendem LGSOC untersucht, bei denen eine vorherige platinbasierte Therapie eine Progression gezeigt hat.",
"description_laie_en": "This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.",
"description_expert_de": "Eine randomisierte, offene Phase-3-Studie zur Kombinationstherapie mit Avutometinib plus Defactinib im Vergleich zur Behandlungswahl des Pr\u00fcfarztes bei Patienten mit rezidivierendem niedriggradigem ser\u00f6sem Eierstockkrebs (LGSOC)",
"description_expert_en": "A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator\u2019s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 3,
"sub_cat_id": 15
}