Dacomitinib (PF-299804) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Dacomitinib has been evaluated across numerous clinical trials and observational studies spanning Early Phase 1 through Phase 4. Primarily focused on EGFR-mutated non-small-cell lung cancer, research also encompasses skin squamous cell carcinoma, recurrent glioblastoma, and pharmacokinetics in healthy volunteers and subjects with severe hepatic impairment. Led by industry sponsors like Pfizer and academic groups such as Grupo Español de Investigación en Neurooncología, these protocols reflect diverse recruitment statuses, including completed, active not recruiting, recruiting, not yet recruiting, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06486142	RECRUITING	Non-Small Cell Lung Cancer	Region Skane	2022-09-21	PHASE3
NCT02925234	RECRUITING	Cancer; Tumors; Neoplasm; Neoplasia	The Netherlands Cancer Institute	2016-08	PHASE2
NCT04946968	ACTIVE_NOT_RECRUITING	Advanced Solid Tumours; Non-small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma	National Cancer Centre, Singapore	2021-08-24	PHASE2
NCT04423185	RECRUITING	Rare Tumor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	2020-08-15	PHASE2
NCT04027647	ACTIVE_NOT_RECRUITING	NSCLC Stage IIIB; NSCLC Stage IIIC; NSCLC Stage IV; Recurrent NSCLC; EGFR Positive Non-Small Cell Lung Cancer	National Cancer Centre, Singapore	2019-09-11	PHASE2
NCT03810807	COMPLETED	Metastatic Non-small Cell Lung Cancer	Memorial Sloan Kettering Cancer Center	2019-01-17	PHASE1
NCT05271916	RECRUITING	Non-Small Cell Lung Cancer (NSCLC)	Shanghai Chest Hospital	2022-10-13	PHASE1; PHASE2
NCT06075615	Not yet recruiting	Carcinoma Non-Small-Cell Lung	Pfizer	2024-09-01	--
NCT06321510	Not yet recruiting	Lung Cancer	Pfizer	2024-04-01	--
NCT04811001	UNKNOWN	NSCLC	Fondazione Ricerca Traslazionale	2020-06-12	PHASE2
NCT03755102	COMPLETED	EGFR Gene Mutation; Lung Cancer; Lung Cancer Metastatic	Memorial Sloan Kettering Cancer Center	2018-11-21	EARLY_PHASE1
NCT04504071	ACTIVE_NOT_RECRUITING	Non-small Cell Lung Cancer Metastatic; EGF-R Positive Non-Small Cell Lung Cancer	Shanghai Chest Hospital	2020-12-08	PHASE2
NCT04511533	COMPLETED	Metastatic Non Small Cell Lung Cancer	Pfizer	2020-08-27	PHASE4
NCT04675008	UNKNOWN	Non Small Cell Lung Cancer; Brain Metastases	Samsung Medical Center	2020-12-07	PHASE2
NCT04339829	UNKNOWN	Dacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases	Guangdong Association of Clinical Trials	2020-08-01	PHASE2
NCT04609319	Active not recruiting	Lung Cancer	Pfizer	2021-01-23	--
NCT03878524	TERMINATED	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma	OHSU Knight Cancer Institute	2020-04-01	PHASE1
NCT01920061	COMPLETED	Neoplasm	Pfizer	2013-09-10	PHASE1
NCT03865446	COMPLETED	Severe Hepatic Impairment	Pfizer	2019-04-05	PHASE1
NCT02382796	COMPLETED	NSCLC	Pfizer	2015-07-10	PHASE2
NCT03865446	Completed	Severe Hepatic Impairment	Pfizer	2019-04-05	Phase 1
NCT01728233	COMPLETED	Penile Neoplasms; Carcinoma, Squamous Cell	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	2013-06-15	PHASE2
NCT02039336	COMPLETED	Colorectal Cancer	The Netherlands Cancer Institute	2014-04-02	PHASE1; PHASE2
NCT02268747	UNKNOWN	Skin Squamous Cell Cancer	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	2014-11	PHASE2
NCT01918761	TERMINATED	Non Small Cell Lung Cancer	Central European Cooperative Oncology Group	2013-07-30	PHASE1
NCT01774721	COMPLETED	Non-small Cell Lung Cancer With EGFR-Activating Mutations	Pfizer	2013-05-09	PHASE3
NCT02047747	TERMINATED	Brain Cancer	David Piccioni, M.D., Ph.D	2014-02	PHASE2
NCT01858389	COMPLETED	Non-small Cell Lung Cancer	Pfizer	2013-07	PHASE2
NCT02382796	Completed	NSCLC	Pfizer	2015-07-10	Phase 2
NCT01465802	COMPLETED	Non Small Cell Lung Cancer (NSCLC)	Pfizer	2011-12-26	PHASE2
NCT01520870	COMPLETED	Glioblastoma; Brain Tumor, Recurrent	Grupo Español de Investigación en Neurooncología	2012-02	PHASE2
NCT01737008	COMPLETED	Squamous Cell Carcinoma of the Head and Neck	University Health Network, Toronto	2013-01	PHASE1
NCT02268747	Unknown status	Skin Squamous Cell Cancer	Fondazione IRCCS Istituto Nazionale dei Tumori Milano	2014-11	Phase 2
NCT02097433	COMPLETED	Healthy	Pfizer	2014-07	PHASE1
NCT01360554	COMPLETED	Non-Small Cell Lung Cancer	Pfizer	2011-06-16	PHASE3
NCT01796327	COMPLETED	Healthy Volunteers	Pfizer	2013-04	PHASE1
NCT01702506	COMPLETED	Healthy Volunteers	Pfizer	2012-10	PHASE1
NCT01571388	COMPLETED	Healthy; Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction	Pfizer	2012-04	PHASE1
NCT00818441	COMPLETED	Carcinoma, Non-small Cell	Pfizer	2009-03-11	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-14)

Check the Dacomitinib (PF-299804) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dacomitinib is a potent, irreversible pan-ErbB tyrosine kinase inhibitor that covalently binds to EGFR, ERBB2, and ERBB4, effectively blocking receptor autophosphorylation and downstream oncogenic signal transduction pathways. This sustained signaling blockade suppresses tumor cell proliferation and induces apoptosis, providing therapeutic efficacy in non-small-cell lung cancer and other ErbB-driven solid tumors evaluated across clinical studies.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).