Estado del programa
Activo, no reclutaFase
Fase 1Inmunoterapia previa permitida
SíEnsayo dirigido por el CRC
SíDrogas
cetuximab, encorafenib, ZN-c3Etiquetas
MSI-H/ MMRd, MSS/ MMRpComentarios
Only for patients with metastatic BRAF V600E mutant colorectal cancer. Must have been previously treated with one or two treatment regimens.
ZN-c3: azenosertib; experimental Wee1 inhibitor. Oral.
Encorafenib: small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway (Braftovi®). Oral.
Cetuximab: (Erbitux®) epidermal growth factor receptor (EGFR) inhibitor. Intravenous.
Enlaces útiles
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8891215/ https://www.cabrini.com.au/app/uploads/55.-Gary-Richardson-Wee1-inhibitor.pdfUbicación | Situación |
---|---|
Estados Unidos | |
USC Norris Comprehensive Cancer Center Los Angeles, California 90033 |
Activo, no recluta |
Alliance for Multispecialty Research, LLC Merriam, Kansas 66204 |
Activo, no recluta |
University of Texas MD Anderson Cancer Center Houston, Texas 77030 |
Activo, no recluta |
Australia | |
The Queen Elizabeth Hospital Woodville South, South Australia 5011 |
Activo, no recluta |
Centro Oncológico Peter MacCallum Melbourne, Victoria 3000 |
Activo, no recluta |
Alemania | |
Hämatologie- Onkologie im Zentrum MVZ GmbH Augsburg, Bayern 86150 |
Activo, no recluta |
Klinikum der Universität München Großhadern Muenchen, Bayern 81377 |
Activo, no recluta |
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie Muenchen, Bayern 81737 |
Activo, no recluta |
Institut für Klinisch Onkologische Forschung Frankfurt, Hessen 60488 |
Activo, no recluta |
DRK Kliniken Berlin - Köpenick Berlin 12559 |
Activo, no recluta |
Hungary | |
Semmelweis University-Department of Internal Medicine and Oncology Budapest 1083 |
Activo, no recluta |
Clinexpert Kft. Bugat Pal Korhaz Gyöngyös 3200 |
Activo, no recluta |
Italia | |
Istituto Nazionale Tumori IRCCS Fondazione Pascale Nápoles, Campania 80131 |
Activo, no recluta |
IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo, Foggia 71013 |
Activo, no recluta |
AOUI Verona Verona, Veneto 37126 |
Activo, no recluta |
Instituto Europeo de Oncología Milano 20141 |
Activo, no recluta |
ASST Grande Ospedale Metropolitano Niguarda Milano 20162 |
Activo, no recluta |
Polonia | |
Szpital Uniwersytecki w Krakowie Kraków, Malopolskie 31-501 |
Activo, no recluta |
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Kraków, Malopolskie 31-826 |
Activo, no recluta |
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Warsaw, Mazowieckie 02-034 |
Activo, no recluta |
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego Opole, Opolskie 45-061 |
Activo, no recluta |
España | |
Parc de Salut Mar - Hospital del Mar Barcelona, Cataluna 08003 |
Activo, no recluta |
Hospital Universitario Reina Sofia Córdoba, Cordoba 14004 |
Activo, no recluta |
Fundación Instituto Valenciano de Oncología Valencia, Valenciana, Comunitat 46009 |
Activo, no recluta |
Hospital Universitari Vall d'Hebron Barcelona 08035 |
Activo, no recluta |
Hospital Universitario La Paz Madrid 28046 |
Activo, no recluta |
Hospital Universitario Puerta de Hierro Majadahonda Madrid 28222 |
Activo, no recluta |
Criterios de inclusión
Criterios de inclusión:
* Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma.
* Documented evidence of a BRAF V600E mutation in tumor tissue or blood
* Presence of measurable disease per RECIST version 1.1 guidelines.
* Disease progression after 1 or 2 previous systemic regimens for metastatic disease
* Adequate bone marrow function
* Adequate hepatic and renal function
Criterios de exclusión
Criterios de exclusión:
* Documented clinical disease progression or radiographic disease progression during the screening period
* Leptomeningeal disease.
* Symptomatic brain metastasis.
* Presence of acute or chronic pancreatitis.
* Unable to swallow, retain, and absorb oral medications.
* Clinically significant cardiovascular diseases
* Evidence of active noninfectious pneumonitis.
* Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventions
* Participants with known positivity for HIV
* Active hepatitis B or hepatitis C infection
* Concurrent or previous other malignancy within 2 years of study entry
* Has had an allogeneic tissue/solid organ transplant
* Pregnant or females of childbearing potential who have a positive β-hCG laboratory test result within 14 days prior to enrollment or is breastfeeding