Studie, ve které se dozvíte o studijní medicíně PF-07934040, když je podávána samotná nebo s jinou protirakovinnou terapií u lidí s pokročilými solidními nádory, které mají genetickou mutaci.
Otevřená studie fáze 1 PF-07934040 jako samostatného agens a v kombinaci s jinými cílovými agens u účastníků s pokročilými solidními nádory nesoucími mutace v genu 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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
- Lék: PF-07934040
- Kombinovaný produkt: Gemcitabine
- Kombinovaný produkt: Nab-paclitaxel
- Kombinovaný produkt: Cetuximab
- Kombinovaný produkt: Fluorouracil
- Kombinovaný produkt: Oxaliplatin
- Kombinovaný produkt: Leucovorin
- Kombinovaný produkt: Bevacizumab
- Kombinovaný produkt: Pembrolizumab
- Kombinovaný produkt: Sasanlimab
- Kombinovaný produkt: pemetrexed
- Kombinovaný produkt: Cisplatin
- Kombinovaný produkt: Paclitaxel
- Kombinovaný produkt: Carboplatin
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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-
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Rio Piedras, Portoriko, 00935
- Pan American Center for Oncology Trials, LLC
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-
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Arkansas
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Fayetteville, Arkansas, Spojené státy, 72703
- Highlands Oncology Group, PA
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Rogers, Arkansas, Spojené státy, 72758
- Highlands Oncology Group, PA
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Springdale, Arkansas, Spojené státy, 72762
- Highlands Oncology Group
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California
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Duarte, California, Spojené státy, 91010
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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Duarte, California, Spojené státy, 91010
- City of Hope Investigational Drug Service (IDS)
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Hospital - Anschutz Outpatient Pavilion
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Hospital
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20016
- Sibley Memorial Hospital
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Michigan
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Grand Rapids, Michigan, Spojené státy, 49546
- START Midwest
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Missouri
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City of Saint Peters, Missouri, Spojené státy, 63376
- Siteman Cancer Center - St Peters
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Creve Coeur, Missouri, Spojené státy, 63141
- Siteman Cancer Center - West County
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Florissant, Missouri, Spojené státy, 63031
- Siteman Cancer Center - North County
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St Louis, Missouri, Spojené státy, 63110
- Barnes-Jewish Hospital
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St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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St Louis, Missouri, Spojené státy, 63129
- Siteman Cancer Center - South County
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St Louis, Missouri, Spojené státy, 63108
- Siteman Cancer Center
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North Carolina
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Durham, North Carolina, Spojené státy, 27710
- Duke University Medical Center
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Durham, North Carolina, Spojené státy, 27710
- Duke University Medical Center, lnvestigational Chemotherapy Service
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- University of Cincinnati Medical Center
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Taussig Cancer Center
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West Chester, Ohio, Spojené státy, 45069
- West Chester Hospital
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Rhode Island Hospital
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Providence, Rhode Island, Spojené státy, 02906
- Miriam Hospital
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Texas
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Houston, Texas, Spojené státy, 77030
- University of Texas MD Anderson Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor.
ECOG PS 0 or 1
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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.
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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:
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Active or history of pneumonitis/ILD or pulmonary fibrosis requiring treatment with systemic steroid therapy.
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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.
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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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Part 1
PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Ostatní jména:
|
|
Experimentální: Part 2a Cohort A1
Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Ostatní jména:
|
|
Experimentální: Part 2a Cohort B1
Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Ostatní jména:
|
|
Experimentální: Part 2a Cohort C1
Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Ostatní jména:
|
|
Experimentální: Part 2a Cohort D1
Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Chemotherapy (antimetabolite)
Ostatní jména:
Taxane-type Chemotherapy
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Monoclonal Antibody (EGFR Inhibitor)
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Ostatní jména:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Ostatní jména:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Ostatní jména:
VEG-F inhibitor
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Monoclonal Antibody (EGFR Inhibitor)
Ostatní jména:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Ostatní jména:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Ostatní jména:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
immune checkpoint inhibitor (PD-1 inhibitor)
Ostatní jména:
immune checkpoint inhibitor (PD-1 inhibitor)
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
immune checkpoint inhibitor (PD-1 inhibitor)
Ostatní jména:
Can be used in Platinum-based Chemotherapy regimen Antimetabolite
Ostatní jména:
Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent)
Ostatní jména:
Can be used in Platinum-based chemotherapy regimen Taxane
Ostatní jména:
Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent)
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Part 1 & 2: Incidence of Adverse Events (AEs)
Časové okno: 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)
|
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PART 1 & 2: Number of participants with laboratory abnormalities
Časové okno: 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)
Časové okno: 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
|
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Part 2: Objective Response - Number of Participants With Objective Response (alone or in combination)
Časové okno: 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'
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Part 1 & 2: Maximum Observed Serum Concentration (Cmax)
Časové okno: 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)
|
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Part 1& 2: Time to Reach Maximum Observed Serum Concentration (Tmax)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- Rakovina plic
- NSCLC
- Nemalobuněčný karcinom plic
- Kolorektální karcinom
- Karcinom, nemalobuněčné plíce
- Rakovina konečníku
- Rakovina tlustého střeva
- Kolorektální karcinom
- Kolorektální novotvary
- KRAS
- CRC
- Nemalobuněčný karcinom plic
- MSS CRC
- Kolorektální nádory
- Novotvary, kolorektální
- duktální adenokarcinom slinivky břišní
- Nemalobuněčný karcinom plic
- Nemalobuněčný karcinom plic
- Karcinom, pankreatický duktální
- G12V
- G12C
- Mutace genu KRAS
- G12D
- G12R
- G12S
- G13D
- Q61H
- Duktální karcinom pankreatu
- Karcinom, duktální, pankreatický
- Duct-cell karcinom slinivky břišní
- Karcinom z kanálků, slinivky břišní
- Duktální karcinom slinivky břišní
- Karcinom buněk slinivky břišní
- PADC
Další relevantní podmínky MeSH
- Onemocnění endokrinního systému
- Novotvary podle místa
- Novotvary
- Střevní nemoci
- Nemoci dýchacích cest
- Novotvary podle histologického typu
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Střevní novotvary
- Rektální onemocnění
- Plicní onemocnění
- Novotvary endokrinních žláz
- Onemocnění slinivky břišní
- Novotvary, žlázové a epiteliální
- Adenokarcinom
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Onemocnění tlustého střeva
- Karcinom
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary, duktální, lobulární a medulární
- Novotvary pankreatu
- Karcinom, duktální
- Rektální novotvary
- Novotvary plic
- Kolorektální novotvary
- Novotvary tlustého střeva
- Karcinom, nemalobuněčné plíce
- Karcinom, pankreatický duktální
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Uhlovodíky
- Cykloparafiny
- Uhlovodíky, alicyklické
- Uhlovodíky, cyklické
- Terpeny
- Enzymy a koenzymy
- Protilátky, monoklonální, humanizované
- Protilátky, monoklonální
- Protilátky
- Imunoglobuliny
- Imunoproteiny
- Krevní proteiny
- Sérové globuliny
- Globuliny
- Anorganické chemikálie
- Sloučeniny chloru
- Sloučeniny dusíku
- Koordinační komplexy
- Guanine
- Hypoxanthiny
- Purinony
- Puriny
- Glutamáty
- Aminokyseliny, kyselé
- Aminokyseliny
- Aminokyseliny, dikarboxylové
- Taxoidy
- Cyclodecanes
- Diterpeny
- Deoxycytidin
- Cytidin
- Pyrimidinové nukleosidy
- Pyrimidiny
- Formyltetrahydrofoláty
- Tetrahydrofoláty
- Kyselina listová
- Pteriny
- Pteridiny
- Uracil
- Pyrimidinony
- Koenzymy
- Platinové sloučeniny
- Albuminy
- Oxaliplatina
- Bevacizumab
- Paklitaxel vázaný na albumin
- Pemetrexed
- Cetuximab
- Gemcitabin
- Fluorouracil
- Karboplatina
- Leukovorin
- Paklitaxel
- Cisplatina
- Pembrolizumab
- 130 nm albumin vázaný na paclitaxel
Další identifikační čísla studie
Další identifikační čísla studie
- C5421001
- NCT06447662 (Identifikátor registru: ClinicalTrials.gov)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .