Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Description for laymen
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
JSON Data
{
"short_title": "INTRINSIC (WO42758)",
"data_mode": "900",
"data_mode_number": "000002291",
"official_title": "A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT04929223",
"eudract_number": null,
"general_contact_email": "oncostudy@ukdd.de",
"general_contact_phone": "+49 351-4587666",
"hauptpruefer_dd_name": "Prof. Dr. med. Gunnar Folprecht",
"description_laie_de": "Diese offene, explorative Studie soll die Sicherheit und Wirksamkeit von zielgerichteten Therapien oder Immuntherapien als Einzelwirkstoffe oder Kombinationen bei Teilnehmern mit metastasiertem kolorektalem Karzinom (mCRC) untersuchen, deren Tumore gem\u00e4\u00df der behandlungsarmspezifischen Definition Biomarker-positiv sind. Die f\u00fcr die Studie in Frage kommenden Teilnehmer mit metastasiertem kolorektalem Karzinom werden auf der Grundlage ihrer Biomarker-Testergebnisse in bestimmte Behandlungsarme eingeteilt.",
"description_laie_en": "This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.",
"description_expert_de": "Diese offene, explorative Studie soll die Sicherheit und Wirksamkeit von zielgerichteten Therapien oder Immuntherapien als Einzelwirkstoffe oder Kombinationen bei Teilnehmern mit metastasiertem kolorektalem Karzinom (mCRC) untersuchen, deren Tumore gem\u00e4\u00df der behandlungsarmspezifischen Definition Biomarker-positiv sind. Die f\u00fcr die Studie in Frage kommenden Teilnehmer mit metastasiertem kolorektalem Karzinom werden auf der Grundlage ihrer Biomarker-Testergebnisse in bestimmte Behandlungsarme eingeteilt.",
"description_expert_en": "This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I",
"main_cat_id": 2,
"sub_cat_id": 6
}
