Um estudo para aprender sobre o medicamento do estudo PF-07934040 quando administrado sozinho ou com outras terapias anticâncer em pessoas com tumores sólidos avançados que apresentam uma mutação genética.
Um estudo aberto de fase 1 de PF-07934040 como agente único e em combinação com outros agentes direcionados em participantes com tumores sólidos avançados que abrigam mutações no gene 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Medicamento: PF-07934040
- Produto combinado: Gemcitabine
- Produto combinado: Nab-paclitaxel
- Produto combinado: Cetuximab
- Produto combinado: Fluorouracil
- Produto combinado: Oxaliplatin
- Produto combinado: Leucovorin
- Produto combinado: Bevacizumab
- Produto combinado: Pembrolizumab
- Produto combinado: Sasanlimab
- Produto combinado: pemetrexed
- Produto combinado: Cisplatin
- Produto combinado: Paclitaxel
- Produto combinado: Carboplatin
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Arkansas
-
Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group, PA
-
Rogers, Arkansas, Estados Unidos, 72758
- Highlands Oncology Group, PA
-
Springdale, Arkansas, Estados Unidos, 72762
- Highlands Oncology Group
-
-
California
-
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
-
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
-
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, Porto Rico, 00935
- Pan American Center for Oncology Trials, LLC
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
-
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.
-
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.
-
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Part 1
PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Outros nomes:
|
|
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
Outros nomes:
|
|
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
Outros nomes:
|
|
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
Outros nomes:
|
|
Experimental: Part 2a Cohort D1
Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Outros nomes:
|
|
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
Outros nomes:
Chemotherapy (antimetabolite)
Outros nomes:
Taxane-type Chemotherapy
Outros nomes:
|
|
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
Outros nomes:
Monoclonal Antibody (EGFR Inhibitor)
Outros nomes:
|
|
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
Outros nomes:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Outros nomes:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Outros nomes:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Outros nomes:
VEG-F inhibitor
Outros nomes:
|
|
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
Outros nomes:
Monoclonal Antibody (EGFR Inhibitor)
Outros nomes:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Outros nomes:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Outros nomes:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Outros nomes:
|
|
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
Outros nomes:
immune checkpoint inhibitor (PD-1 inhibitor)
Outros nomes:
immune checkpoint inhibitor (PD-1 inhibitor)
Outros nomes:
|
|
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
Outros nomes:
immune checkpoint inhibitor (PD-1 inhibitor)
Outros nomes:
Can be used in Platinum-based Chemotherapy regimen Antimetabolite
Outros nomes:
Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent)
Outros nomes:
Can be used in Platinum-based chemotherapy regimen Taxane
Outros nomes:
Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent)
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Part 1 & 2: Incidence of Adverse Events (AEs)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Part 1 & 2: Maximum Observed Serum Concentration (Cmax)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Câncer de pulmão
- NSCLC
- Câncer de Pulmão de Células Não Pequenas
- Câncer colorretal
- Carcinoma pulmonar de células não pequenas
- Câncer retal
- Cancer de colo
- Carcinoma Colorretal
- Neoplasias Colorretais
- KRAS
- CRC
- Carcinoma pulmonar de células não pequenas
- MSS CRC
- Tumores Colorretais
- Neoplasias Colorretais
- adenocarcinoma ductal pancreático
- Carcinoma Pulmonar de Células Não Pequenas
- Câncer de Pulmão de Células Não Pequenas
- Carcinoma Ductal Pancreático
- G12V
- G12C
- Mutação do gene KRAS
- G12D
- G12R
- G12S
- G13D
- Q61H
- Carcinoma Ductal Pancreático
- Carcinoma Ductal Pancreático
- Carcinoma de células ductais do pâncreas
- Carcinoma de células ductais do pâncreas
- Carcinoma Ductal do Pâncreas
- Carcinoma de células ductais pancreáticas
- PADC
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Neoplasias por local
- Neoplasias
- Doenças Intestinais
- Doenças Respiratórias
- Neoplasias por Tipo Histológico
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças pulmonares
- Neoplasias das Glândulas Endócrinas
- Doenças pancreáticas
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Doenças do cólon
- Carcinoma
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Ductal, Lobular e Medular
- Neoplasias Pancreáticas
- Carcinoma Ductal
- Neoplasias retais
- Neoplasias Pulmonares
- Neoplasias Colorretais
- Neoplasias colônicas
- Carcinoma pulmonar de células não pequenas
- Carcinoma Ductal Pancreático
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Hidrocarbonetos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Terpenos
- Enzimas e coenzimas
- Anticorpos, monoclonais, humanizados
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Produtos químicos inorgânicos
- Compostos de cloro
- Compostos de nitrogênio
- Complexos de coordenação
- Guanina
- Hipoxantinas
- Purinonas
- Purinas
- Glutamatos
- Aminoácidos, ácido
- Aminoácidos
- Aminoácidos, dicarboxílico
- Taxóides
- Ciclodecanos
- Diterpenos
- Desoxicitidina
- Citidina
- Nucleosídeos de pirimidina
- Pirimidinas
- Formiltetra -hidrofolatos
- Tetra -hidrofolatos
- Ácido fólico
- Pterins
- Pteridinas
- Uracil
- Pirimidinonas
- Coenzimas
- Compostos de platina
- Álbumins
- Oxaliplatina
- Bevacizumabe
- Paclitaxel ligado à albumina
- Pemetrexede
- Cetuximabe
- Gemcitabina
- Fluorouracila
- Carboplatina
- Leucovorina
- Paclitaxel
- Cisplatina
- Pembrolizumab
- Paclitaxel com 130 nm de albumina
Outros números de identificação do estudo
- C5421001
- NCT06447662 (Identificador de registro: ClinicalTrials.gov)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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