Activo, sin reclutamientoNCT06106308Registro de ClinicalTrials.gov

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation

Metastatic Colorectal Cancer · CRC · KRAS/NRAS Mutation

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 110 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Histologically confirmed metastatic colorectal cancer.
Documented KRAS or NRAS mutation.
No previous systemic therapy in the metastatic setting.
Participants must be willing to submit archival tissue or undergo fresh biopsy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Women of childbearing potential must use contraception or take measures to avoid pregnancy.
Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis and other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib.
Must have acceptable organ function

Exclusion Criteria:

Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instability high/deficient mismatch repair.
Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
Previous oxaliplatin treatment within 12 months prior to randomization, when arm open.
Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Anticancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug.
Untreated or symptomatic brain metastasis.
Gastrointestinal (GI) disorder(s) that would significantly impede the absorption of an oral agent.
Unable or unwilling to swallow study drug.
Uncontrolled intercurrent illness.
Known hypersensitivity to fluoropyrimidine or leucovorin, irinotecan, or oxalipatin.
Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers.
QTc \>470

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

Onvansertib 20mg + Standard of Care

Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI/BEV on Day 1 and Day 15 of each 28-day treatment cycle.

Drug: Onvansertib · Drug: FOLFIRI · Drug: Bevacizumab

Onvansertib 30 mg + Standard of Care (SOC)

Participants will receive 30 mg of onvansertib + on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI on Day 1 and Day 15 of each 28-day treatment cycle.

Drug: Onvansertib · Drug: FOLFIRI · Drug: Bevacizumab

Standard of Care (SOC)

Participants will receive FOLFIRI/Bev on Day 1 and Day 15 of each 28-day treatment cycle.

Drug: FOLFIRI · Drug: Bevacizumab

Onvansertib 20 mg + Standard of Care

Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle.

Drug: Onvansertib · Drug: Bevacizumab · Drug: FOLFOX

Onvansertib 30 mg + Standard of Care

Participants will receive 30 mg onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle.

Drug: Onvansertib · Drug: Bevacizumab · Drug: FOLFOX

Standard of Care

Participants will receive FOLFOX/Bev on Day 1 and Day 15 of each 28-day treatment cycle.

Drug: Bevacizumab · Drug: FOLFOX

Onvansertib DRUG

Oral capsule

FOLFIRI DRUG

FOLFIRI (irinotecan + fluorouracil \[5-FU\] + leucovorin) as intravenous (IV) infusion

Bevacizumab DRUG

IV Infusion

FOLFOX DRUG

FOLFOX (leucovorin + fluorouracil \[5-FU\] + oxaliplatin) as intravenous (IV) infusion

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Objective Response Rate (ORR)

Plazo: Up to approximately 1 year

ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause, as determined by blinded independent central review.

Medidas secundarias

Progression Free Survival (PFS)

Plazo: Up to approximately 1 year

PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause, as determined by blinded independent central review.

Duration of Response (DOR)

Plazo: Up to approximately 1 year

DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause, as determined by blinded independent central review.

Number of Participants with an Adverse Event (AE)

Plazo: Up to approximately 1 year

Type, incidence, causality and severity of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Clinically significant changes from baseline in vital signs, laboratory parameters, electrocardiograms (ECGs), weight, and Eastern Cooperative Oncology Group (ECOG) performance status will be recorded as AEs.

Disease Control Rate (DCR)

Plazo: Up to approximately 1 year

DCR defined as CR plus PR plus stable disease (SD), as determined by independent central review.

Overall Survival (OS)

Plazo: Up to approximately 1 year

OS defined as the time from drug administration to death due to any cause.

Overall Response (OR)

Plazo: Up to approximately 1 year

Defined as CR or PR, PFS, DCR, DOR, and OS associated with a reduction in circulating tumor DNA (ctDNA) mutation allele frequency (MAF).

Maximum Concentration (Cmax) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab

Plazo: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)

No informado en este registro.

Area Under the Plasma Concentration Curve (AUC) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab

Plazo: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)

No informado en este registro.

Trough Concentration (Ctrough) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab

Plazo: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)

No informado en este registro.

Efficacy: Exposure Response Evaluation of Onvansertib

Plazo: Up to approximately 1 year

No informado en este registro.

Safety: Exposure Response Evaluation of Onvansertib

Plazo: Up to approximately 1 year

No informado en este registro.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (41)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

Buscar un centro en este estudio

41 centros

Mayo Clinic - ArizonaPhoenix, Arizona, United StatesEstado desconocido

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (41)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research