Une étude pour en savoir plus sur le médicament à l'étude PF-07934040 lorsqu'il est administré seul ou avec d'autres thérapies anticancéreuses chez les personnes atteintes de tumeurs solides avancées présentant une mutation génétique.
Une étude ouverte de phase 1 sur le PF-07934040 en monothérapie et en association avec d'autres agents ciblés chez des participants atteints de tumeurs solides avancées hébergeant des mutations dans le gène 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Médicament: PF-07934040
- Produit combiné: Gemcitabine
- Produit combiné: Nab-paclitaxel
- Produit combiné: Cetuximab
- Produit combiné: Fluorouracil
- Produit combiné: Oxaliplatin
- Produit combiné: Leucovorin
- Produit combiné: Bevacizumab
- Produit combiné: Pembrolizumab
- Produit combiné: Sasanlimab
- Produit combiné: pemetrexed
- Produit combiné: Cisplatin
- Produit combiné: Paclitaxel
- Produit combiné: Carboplatin
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Rio Piedras, Porto Rico, 00935
- Pan American Center for Oncology Trials, LLC
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Arkansas
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Fayetteville, Arkansas, États-Unis, 72703
- Highlands Oncology Group, PA
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Rogers, Arkansas, États-Unis, 72758
- Highlands Oncology Group, PA
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Springdale, Arkansas, États-Unis, 72762
- Highlands Oncology Group
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California
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Duarte, California, États-Unis, 91010
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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Duarte, California, États-Unis, 91010
- City of Hope Investigational Drug Service (IDS)
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Hospital - Anschutz Outpatient Pavilion
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Hospital
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20016
- Sibley Memorial Hospital
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Michigan
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Grand Rapids, Michigan, États-Unis, 49546
- START Midwest
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Missouri
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City of Saint Peters, Missouri, États-Unis, 63376
- Siteman Cancer Center - St Peters
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Creve Coeur, Missouri, États-Unis, 63141
- Siteman Cancer Center - West County
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Florissant, Missouri, États-Unis, 63031
- Siteman Cancer Center - North County
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St Louis, Missouri, États-Unis, 63110
- Barnes-Jewish Hospital
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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St Louis, Missouri, États-Unis, 63129
- Siteman Cancer Center - South County
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St Louis, Missouri, États-Unis, 63108
- Siteman Cancer Center
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center, lnvestigational Chemotherapy Service
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- University of Cincinnati Medical Center
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Taussig Cancer Center
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West Chester, Ohio, États-Unis, 45069
- West Chester Hospital
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital
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Providence, Rhode Island, États-Unis, 02906
- Miriam Hospital
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Texas
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Houston, Texas, États-Unis, 77030
- University of Texas MD Anderson Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
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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].
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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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Part 1
PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Autres noms:
|
|
Expérimental: Part 2a Cohort A1
Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Autres noms:
|
|
Expérimental: Part 2a Cohort B1
Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Autres noms:
|
|
Expérimental: Part 2a Cohort C1
Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Autres noms:
|
|
Expérimental: Part 2a Cohort D1
Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles |
panKRAS inhibitor
Autres noms:
|
|
Expérimental: 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
Autres noms:
Chemotherapy (antimetabolite)
Autres noms:
Taxane-type Chemotherapy
Autres noms:
|
|
Expérimental: 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
Autres noms:
Monoclonal Antibody (EGFR Inhibitor)
Autres noms:
|
|
Expérimental: 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
Autres noms:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Autres noms:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Autres noms:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Autres noms:
VEG-F inhibitor
Autres noms:
|
|
Expérimental: 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
Autres noms:
Monoclonal Antibody (EGFR Inhibitor)
Autres noms:
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Autres noms:
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Autres noms:
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Autres noms:
|
|
Expérimental: 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
Autres noms:
immune checkpoint inhibitor (PD-1 inhibitor)
Autres noms:
immune checkpoint inhibitor (PD-1 inhibitor)
Autres noms:
|
|
Expérimental: 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
Autres noms:
immune checkpoint inhibitor (PD-1 inhibitor)
Autres noms:
Can be used in Platinum-based Chemotherapy regimen Antimetabolite
Autres noms:
Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent)
Autres noms:
Can be used in Platinum-based chemotherapy regimen Taxane
Autres noms:
Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Part 1 & 2: Incidence of Adverse Events (AEs)
Délai: 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
Délai: 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
|
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Part 1: Number of participants with Dose-limiting toxicities (DLT)
Délai: Baseline up to 28 days
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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)
Délai: 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'
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Part 1 & 2: Maximum Observed Serum Concentration (Cmax)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Cancer du poumon
- NSCLC
- Cancer du poumon non à petites cellules
- Cancer colorectal
- Carcinome pulmonaire non à petites cellules
- Cancer rectal
- Cancer du colon
- Carcinome colorectal
- Tumeurs colorectales
- KRAS
- CRC
- Carcinome pulmonaire non à petites cellules
- MSS CRC
- Tumeurs colorectales
- Tumeurs colorectales
- adénocarcinome canalaire pancréatique
- Carcinome pulmonaire non à petites cellules
- Cancer du poumon non à petites cellules
- Carcinome canalaire pancréatique
- G12V
- G12C
- Mutation du gène KRAS
- G12D
- G12R
- G12S
- G13D
- Q61H
- Carcinome canalaire pancréatique
- Carcinome canalaire, pancréatique
- Carcinome canalaire-cellulaire du pancréas
- Carcinome canalaire-cellulaire, pancréas
- Carcinome canalaire du pancréas
- Carcinome cellulaire du canal pancréatique
- PADC
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Tumeurs par site
- Tumeurs
- Maladies intestinales
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs intestinales
- Maladies rectales
- Maladies pulmonaires
- Tumeurs des glandes endocrines
- Maladies pancréatiques
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Maladies du côlon
- Carcinome
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs canalaires, lobulaires et médullaires
- Tumeurs pancréatiques
- Carcinome canalaire
- Tumeurs rectales
- Tumeurs pulmonaires
- Tumeurs colorectales
- Tumeurs du côlon
- Carcinome pulmonaire non à petites cellules
- Carcinome canalaire pancréatique
- Acides aminés, peptides et protéines
- Protéines
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Hydrocarbures
- Cycloparaffines
- Hydrocarbures, alicyclique
- Hydrocarbures, cyclique
- Terpènes
- Enzymes et coenzymes
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Produits chimiques inorganiques
- Composés de chlore
- Composés d'azote
- Complexes de coordination
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Glutamates
- Acides aminés, acides
- Acides aminés
- Acides aminés, dicarboxylique
- Taxes
- Cyclodécanes
- Diterpènes
- Désoxycytidine
- Cytidine
- Nucléosides pyrimidine
- Pyrimidines
- Formyltétrahydrofolate
- Tétrahydrofolat
- Acide folique
- Pterines
- Ptéridines
- Uracile
- Pyrimidinones
- Coenzymes
- Composés en platine
- Albumines
- Oxaliplatine
- Bévacizumab
- Paclitaxel lié à l'albumine
- Pémétrexed
- Cétuximab
- Gemcitabine
- Fluorouracile
- Carboplatine
- Leucovorine
- Paclitaxel
- Cisplatine
- pembrolizumab
- Paclitaxel lié à l'albumine de 130 nm
Autres numéros d'identification d'étude
- C5421001
- NCT06447662 (Identificateur de registre: ClinicalTrials.gov)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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