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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.

9. října 2026 aktualizováno: Pfizer

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

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

64

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Portoriko
      • Rio Piedras, Portoriko, 00935
        • Pan American Center for Oncology Trials, LLC
  • Spojené státy
    • Arkansas
      • Fayetteville, Arkansas, Spojené státy, 72703
        • Highlands Oncology Group, PA
      • Rogers, Arkansas, Spojené státy, 72758
        • Highlands Oncology Group, PA
      • Springdale, Arkansas, Spojené státy, 72762
        • Highlands Oncology Group
    • California
      • Duarte, California, Spojené státy, 91010
        • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
      • Duarte, California, Spojené státy, 91010
        • City of Hope Investigational Drug Service (IDS)
    • Colorado
      • Aurora, Colorado, Spojené státy, 80045
        • University of Colorado Hospital - Anschutz Outpatient Pavilion
      • Aurora, Colorado, Spojené státy, 80045
        • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
      • Aurora, Colorado, Spojené státy, 80045
        • University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
      • Aurora, Colorado, Spojené státy, 80045
        • University of Colorado Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Spojené státy, 20016
        • Sibley Memorial Hospital
    • Michigan
      • Grand Rapids, Michigan, Spojené státy, 49546
        • START Midwest
    • Missouri
      • City of Saint Peters, Missouri, Spojené státy, 63376
        • Siteman Cancer Center - St Peters
      • Creve Coeur, Missouri, Spojené státy, 63141
        • Siteman Cancer Center - West County
      • Florissant, Missouri, Spojené státy, 63031
        • Siteman Cancer Center - North County
      • St Louis, Missouri, Spojené státy, 63110
        • Barnes-Jewish Hospital
      • St Louis, Missouri, Spojené státy, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Spojené státy, 63129
        • Siteman Cancer Center - South County
      • St Louis, Missouri, Spojené státy, 63108
        • Siteman Cancer Center
    • North Carolina
      • Durham, North Carolina, Spojené státy, 27710
        • Duke University Medical Center
      • Durham, North Carolina, Spojené státy, 27710
        • Duke University Medical Center, lnvestigational Chemotherapy Service
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, Spojené státy, 44195
        • Cleveland Clinic Taussig Cancer Center
      • West Chester, Ohio, Spojené státy, 45069
        • West Chester Hospital
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, Spojené státy, 02906
        • Miriam Hospital
    • Texas
      • Houston, Texas, Spojené státy, 77030
        • University of Texas MD Anderson Cancer Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

    1. PDAC, CRC, Other tumor types: Confirmed KRAS mutation, any variant
    2. 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.

    1. 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.
    2. 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.
    3. 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;
    4. 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:

    1. 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.
    2. 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.
    3. 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.
    4. NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not have received prior systemic treatment setting.
    5. 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.

  • 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)).

  • Hematologic abnormalities.

  • Renal impairment.

    • Hepatic abnormalities.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Part 1

PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Experimentální: Part 2a Cohort A1

Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Experimentální: Part 2a Cohort B1

Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Experimentální: Part 2a Cohort C1

Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Experimentální: Part 2a Cohort D1

Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
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
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Kombinovaný produkt: Gemcitabine

Chemotherapy (antimetabolite)

Ostatní jména:
  • Gemzar
Kombinovaný produkt: Nab-paclitaxel

Taxane-type Chemotherapy

Ostatní jména:
  • Abraxane
Experimentální: Part 2b Cohort B2

Combination (PF-07934040 + Cetuximab) dose escalation/expansion in 2-3L CRC

Prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Kombinovaný produkt: Cetuximab

Monoclonal Antibody (EGFR Inhibitor)

Ostatní jména:
  • Erbitux
Experimentální: Part 2b Cohort B3

Combination (PF-07934040 + FOLFOX + Bevacizumab) dose escalation/expansion in 1L CRC

Prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Kombinovaný produkt: Fluorouracil

Part of FOLFOX chemotherapy regimen

cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

Ostatní jména:
  • 5-FU
  • 5-fluorouracil
Kombinovaný produkt: Oxaliplatin

Part of FOLFOX Chemotherapy Regimen

platinum based compound (alkylating agent)

Ostatní jména:
  • Eloxatin
Kombinovaný produkt: Leucovorin

Part of FOLFOX chemotherapy regimen

Folic Acid Analog

Ostatní jména:
  • Wellcovorin
  • Kyselina folinová
  • kalciumfolinát
  • Leukovorin vápník
Kombinovaný produkt: Bevacizumab

VEG-F inhibitor

Ostatní jména:
  • Avastin
  • Zirabev
Experimentální: Part 2b Cohort B4

Combination (PF-07934040 + FOLFOX + Cetuximab) dose escalation/expansion in 1L CRC

Prescribed dose and frequency in 28-day cycles
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Kombinovaný produkt: Cetuximab

Monoclonal Antibody (EGFR Inhibitor)

Ostatní jména:
  • Erbitux
Kombinovaný produkt: Fluorouracil

Part of FOLFOX chemotherapy regimen

cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

Ostatní jména:
  • 5-FU
  • 5-fluorouracil
Kombinovaný produkt: Oxaliplatin

Part of FOLFOX Chemotherapy Regimen

platinum based compound (alkylating agent)

Ostatní jména:
  • Eloxatin
Kombinovaný produkt: Leucovorin

Part of FOLFOX chemotherapy regimen

Folic Acid Analog

Ostatní jména:
  • Wellcovorin
  • Kyselina folinová
  • kalciumfolinát
  • Leukovorin vápník
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)
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Kombinovaný produkt: Pembrolizumab

immune checkpoint inhibitor (PD-1 inhibitor)

Ostatní jména:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • Pembro
Kombinovaný produkt: Sasanlimab

immune checkpoint inhibitor (PD-1 inhibitor)

Ostatní jména:
  • PF-06081591
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
Lék: PF-07934040

panKRAS inhibitor

Ostatní jména:
  • PF-4040
Kombinovaný produkt: Pembrolizumab

immune checkpoint inhibitor (PD-1 inhibitor)

Ostatní jména:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • Pembro
Kombinovaný produkt: pemetrexed

Can be used in Platinum-based Chemotherapy regimen

Antimetabolite

Ostatní jména:
  • Alimta
Kombinovaný produkt: Cisplatin

Can be used as part of Platinum-based chemotherapy regimen

Platinum-based antineoplastic (alkylating agent)

Ostatní jména:
  • Cisplatina
  • Platinol
  • neoplatina
Kombinovaný produkt: Paclitaxel

Can be used in Platinum-based chemotherapy regimen

Taxane

Ostatní jména:
  • Taxol
  • Onxol
Kombinovaný produkt: Carboplatin

Can be used as part of a platinum-based chemotherapy regimen

platinum containing compound (alkylating agent)

Ostatní jména:
  • Paraplatin
  • Stricarb

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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)
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
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

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)
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

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Vyšetřovatelé

  • Ředitel studie: Pfizer CT.gov Call Center, Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

27. června 2024

Primární dokončení (Odhadovaný)

9. října 2026

Dokončení studie (Odhadovaný)

9. října 2026

Termíny zápisu do studia

První předloženo

29. května 2024

První předloženo, které splnilo kritéria kontroly kvality

6. června 2024

První zveřejněno (Aktuální)

7. června 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C5421001
  • NCT06447662 (Identifikátor registru: ClinicalTrials.gov)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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 .

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