Un estudio para conocer el medicamento del estudio PF-07934040 cuando se administra solo o con otras terapias contra el cáncer en personas con tumores sólidos avanzados que tienen una mutación genética.
Un estudio de fase 1 de etiqueta abierta de PF-07934040 como agente único y en combinación con otros agentes dirigidos en participantes con tumores sólidos avanzados que albergan mutaciones en el gen KRAS
The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose.
This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that:
- are advanced (cancer that doesn't disappear or stay away with treatment) and
- have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers).
This includes (but limited to) the following cancer types:
Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body.
Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control.
Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels.
All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles.
Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle.
Participants can continue to take the study medication (PF-07934040) and the combination anti-cancer therapy until their cancer is no longer responding.
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.
Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Droga: PF-07934040
- Producto combinado: Gemcitabine
- Producto combinado: Nab-paclitaxel
- Producto combinado: Cetuximab
- Producto combinado: Fluorouracil
- Producto combinado: Oxaliplatin
- Producto combinado: Leucovorin
- Producto combinado: Bevacizumab
- Producto combinado: Pembrolizumab
- Producto combinado: Sasanlimab
- Producto combinado: pemetrexed
- Producto combinado: Cisplatin
- Producto combinado: Paclitaxel
- Producto combinado: Carboplatin
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group, PA
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Rogers, Arkansas, Estados Unidos, 72758
- Highlands Oncology Group, PA
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Springdale, Arkansas, Estados Unidos, 72762
- Highlands Oncology Group
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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Duarte, California, Estados Unidos, 91010
- City of Hope Investigational Drug Service (IDS)
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Hospital - Anschutz Outpatient Pavilion
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Hospital
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20016
- Sibley Memorial Hospital
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49546
- START Midwest
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Missouri
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City of Saint Peters, Missouri, Estados Unidos, 63376
- Siteman Cancer Center - St Peters
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Creve Coeur, Missouri, Estados Unidos, 63141
- Siteman Cancer Center - West County
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Florissant, Missouri, Estados Unidos, 63031
- Siteman Cancer Center - North County
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St Louis, Missouri, Estados Unidos, 63110
- Barnes-Jewish Hospital
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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St Louis, Missouri, Estados Unidos, 63129
- Siteman Cancer Center - South County
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St Louis, Missouri, Estados Unidos, 63108
- Siteman Cancer Center
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center, lnvestigational Chemotherapy Service
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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West Chester, Ohio, Estados Unidos, 45069
- West Chester Hospital
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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Providence, Rhode Island, Estados Unidos, 02906
- Miriam Hospital
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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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Rio Piedras, Puerto Rico, 00935
- Pan American Center for Oncology Trials, LLC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor.
ECOG PS 0 or 1
-
Presence of at least 1 measurable lesion based on RECIST version 1.1 that has not been previously irradiated.
-
Documentation of mutated KRAS gene
- PDAC, CRC, Other tumor types: Confirmed KRAS mutation, any variant
- NSCLC: Confirmed KRAS mutation, any variant except previously treated G12C. If driver mutation, must have failed precision medicine therapy [eg, inhibitors of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), and others].
-
Part 1 and Part 2a: Participant must have progressed on standard treatment(s) for which no additional, effective therapy is available.
- PDAC (2-3L): Participants must have received and radiologically progressed on prior lines of systemic therapy for metastatic pancreatic adenocarcinoma. If participants received prior neoadjuvant or adjuvant chemotherapy and progressed within 6 months of the last dose, then this should be considered as a prior line of systemic therapy.
- NSCLC (2-3L): Participants must have received prior lines of anti-cancer treatment and progressed on at least a platinum-containing chemotherapy regimen or ICI. Participants may have had only one or two prior lines of therapy in the advanced/metastatic setting. For participants with EGFR, ALK, or other genomic tumor alterations, participants must have progressed on approved therapy for these alterations.
- CRC (2-3L): Participants must have had one or two prior lines of therapy for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, oxaliplatin, and/or irinotecan for one prior treatment, exposure to VEGF/VEGF receptor (VEGFR) inhibitor is optional;
- Other tumors: Participants, in the judgment of the investigator, must have progressed or become intolerant to all available standard therapies, or have refused such therapy.
-
Part 2b:
- PDAC (1L) Cohort A2: Participants must not have received prior chemotherapy for metastatic disease. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant treatment or neoadjuvant therapy, the participant would be considered 2L, and not 1L.
- CRC (2-3L) Cohort B2: Participants must have had one or two prior systemic treatment regimens for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin; for one prior treatment, exposure to a VEGF/VEGF receptor (VEGFR) inhibitor is optional.
- CRC (1L) Cohort B3/B4: Participants must not have received prior therapy for metastatic disease and not be a candidate for other targeted therapy or immunotherapy. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant or neoadjuvant therapy, then the participant would be considered 2L, and not 1L.
- NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not have received prior systemic treatment setting.
- NSCLC (1L) Cohort C3: Participants with any TPS and must not have received prior systemic treatment setting.
Exclusion Criteria:
-
Active or history of pneumonitis/ILD or pulmonary fibrosis requiring treatment with systemic steroid therapy.
-
Diagnosis of immunodeficiency or an active autoimmune disease that require systemic treatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy in the past 2 years.
-
Sensory peripheral neuropathy ≥Grade 2
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Active or history of clinically significant gastrointestinal (GI) disease (including but not limited to inflammatory GI disease [eg, ulcerative colitis, Crohn's disease, inflammatory bowel disease], immune-mediated colitis, peptic ulcer disease, GI bleeding, chronic diarrhea) and other conditions that are unresolved and/or may increase the risk associated with study participation or study treatment administration.
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Active bleeding disorder, including GI bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months.
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Major surgery or completion of radiation therapy ≤4 weeks prior to enrollment/randomization or radiation therapy that included >30% of the bone marrow.
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Known sensitivity or contraindication to any component of study intervention (PF 07934040, gemcitabine, nab-paclitaxel, cetuximab, bevacizumab, FOLFOX, 5-FU, pembrolizumab, cisplatin, carboplatin, pemetrexed, SHP2 inhibitor(s), cyclin-dependent kinase (CDK) inhibitor(s), antibody drug conjugates (ADCs) or EGFR inhibitor(s)).
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Hematologic abnormalities.
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Renal impairment.
- Hepatic abnormalities.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Part 1
PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
|
|
Experimental: Part 2a Cohort A1
Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
|
|
Experimental: Part 2a Cohort B1
Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
|
|
Experimental: Part 2a Cohort C1
Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
|
|
Experimental: Part 2a Cohort D1
Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
|
|
Experimental: Part 2b Cohort A2
Combination (PF-07934040 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
Chemotherapy (antimetabolite)
Otros nombres:
Taxane-type Chemotherapy
Otros nombres:
|
|
Experimental: Part 2b Cohort B2
Combination (PF-07934040 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
Monoclonal Antibody (EGFR Inhibitor)
Otros nombres:
|
|
Experimental: Part 2b Cohort B3
Combination (PF-07934040 + FOLFOX + Bevacizumab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Otros nombres:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Otros nombres:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Otros nombres:
VEG-F inhibitor
Otros nombres:
|
|
Experimental: Part 2b Cohort B4
Combination (PF-07934040 + FOLFOX + Cetuximab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Otros nombres:
Monoclonal Antibody (EGFR Inhibitor)
Otros nombres:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Otros nombres:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Otros nombres:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Otros nombres:
|
|
Experimental: Part 2b Cohort C2
Combination (PF-07934040 + Pembro or Sasanlimab) dose escalation/expansion in 1L NSCLC (TPS ≥ 50%) Prescribed dose and frequency in 21-day cycles (for pembro) or 28-day cycles (for sasanlimab) |
panKRAS inhibitor
Otros nombres:
immune checkpoint inhibitor (PD-1 inhibitor)
Otros nombres:
immune checkpoint inhibitor (PD-1 inhibitor)
Otros nombres:
|
|
Experimental: Part 2b Cohort C3
Combination (PF-07934040 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles |
panKRAS inhibitor
Otros nombres:
immune checkpoint inhibitor (PD-1 inhibitor)
Otros nombres:
Can be used in Platinum-based Chemotherapy regimen Antimetabolite
Otros nombres:
Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent)
Otros nombres:
Can be used in Platinum-based chemotherapy regimen Taxane
Otros nombres:
Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1 & 2: Incidence of Adverse Events (AEs)
Periodo de tiempo: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
|
An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs. |
Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
|
|
PART 1 & 2: Number of participants with laboratory abnormalities
Periodo de tiempo: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
|
Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). |
From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
|
|
Part 1: Number of participants with Dose-limiting toxicities (DLT)
Periodo de tiempo: Baseline up to 28 days
|
Any of the prespecified AEs that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes |
Baseline up to 28 days
|
|
Part 2: Objective Response - Number of Participants With Objective Response (alone or in combination)
Periodo de tiempo: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'
|
Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for overall response rate (ORR), progression free survival (PFS), and overall survivor (OS) assessed by the Investigator. |
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1 & 2: Maximum Observed Serum Concentration (Cmax)
Periodo de tiempo: baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents. |
baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
|
Part 1& 2: Time to Reach Maximum Observed Serum Concentration (Tmax)
Periodo de tiempo: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents. |
Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
|
Part 1 & 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Periodo de tiempo: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents. |
Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
|
Part 1 & 2: Changes in pERK levels
Periodo de tiempo: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
Evaluates the intended mechanism of action (MoA) modulation of KRAS inhibition and target engagement effect of PF-07934040 in peripheral blood of participants with advanced solid tumor malignancies. |
Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
|
|
Part 1: Objective Response - Number of Participants With Objective Response
Periodo de tiempo: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years
|
Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator including overall response rate (ORR), progression free survival (PFS), and overall survival (OS). |
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years
|
|
Part 1: Effect of Food on Cmax
Periodo de tiempo: Baseline through end of Cycle 1 (All cycles are 28 days)
|
Evaluate the effect of food on Cmax of PF-07934040 as monotherapy. |
Baseline through end of Cycle 1 (All cycles are 28 days)
|
|
Part 1: Effect of Food on Tmax
Periodo de tiempo: Baseline through end of Cycle 1 (All cycles are 28 days)
|
Evaluate the effect of food on Tmax of PF-07934040 as monotherapy. |
Baseline through end of Cycle 1 (All cycles are 28 days)
|
|
Part 1: Effect of Food on AUClast
Periodo de tiempo: Baseline through end of Cycle 1 (All cycles are 28 days)
|
Evaluate the effect of food on AUClast of PF-07934040 as monotherapy. |
Baseline through end of Cycle 1 (All cycles are 28 days)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Cáncer de pulmón
- NSCLC
- Cáncer de pulmón de células no pequeñas
- Cáncer colonrectal
- Carcinoma de pulmón de células no pequeñas
- Cáncer de recto
- Cáncer de colon
- Carcinoma colorrectal
- Neoplasias colorrectales
- KRAS
- CDN
- Carcinoma de pulmón de células no pequeñas
- MSS CDN
- Tumores colorrectales
- Neoplasias Colorrectales
- adenocarcinoma ductal pancreático
- Carcinoma de pulmón de células no pequeñas
- Cáncer de pulmón de células no pequeñas
- Carcinoma Ductal Pancreático
- G12V
- G12C
- Mutación del gen KRAS
- G12D
- G12R
- G12S
- G13D
- Q61H
- Carcinoma ductal pancreático
- Carcinoma Ductal De Páncreas
- Carcinoma de células ductales de páncreas
- Carcinoma de células ductales, páncreas
- Carcinoma ductal de páncreas
- Carcinoma de células del conducto pancreático
- PADC
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades pulmonares
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Enfermedades del Colon
- Carcinoma
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias ductales, lobulillares y medulares
- Neoplasias pancreáticas
- Carcinoma Ductal
- Neoplasias Rectales
- Neoplasias Pulmonares
- Neoplasias colorrectales
- Neoplasias colónicas
- Carcinoma de pulmón de células no pequeñas
- Carcinoma Ductal Pancreático
- Aminoácidos, péptidos y proteínas
- Proteínas
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Hidrocarburos
- Cicloparafinas
- Hidrocarburos, alicíclicos
- Hidrocarburos, cíclico
- Terpenos
- Enzimas y coenzimas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Químicos inorgánicos
- Compuestos de cloro
- Compuestos de nitrógeno
- Complejos de coordinación
- Guanina
- Hipoxantino
- Purinones
- Purinas
- Glutamatos
- Aminoácidos, ácido
- Aminoácidos
- Aminoácidos, dicarboxílico
- Taxaides
- Ciclodecanos
- Diterpenos
- Desoxicitidina
- Citidina
- Nucleósidos de pirimidina
- Pirimidinas
- Formiltetrahidrofolatos
- Tetrahidrofolatos
- Ácido fólico
- Pterins
- Pteridinas
- Uracílico
- Pirimidinonas
- Coenzimas
- Compuestos de platino
- Albúmina
- Oxaliplatino
- Bevacizumab
- Paclitaxel unido a albúmina
- Pemetrexed
- Cetuximab
- Gemcitabina
- Fluorouracilo
- Carboplatino
- Leucovorina
- Paclitaxel
- Cisplatino
- pembrolizumab
- Paclitaxel de 130 nm en albúmina
Otros números de identificación del estudio
- C5421001
- NCT06447662 (Identificador de registro: ClinicalTrials.gov)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .