Dacomitinib
Information
- Drug Name
- Dacomitinib
- Description
- Entry(CIViC)
- 12
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In this phase II study (NCT00818441) of dacomitini... | ERBB2 |
ERBB2 p.Gly778_Pro780dup (p.G778_P780dup) ( ENST00000584450.5, ENST00000406381.6, ENST00000584601.5, ENST00000541774.5, ENST00000269571.10, ENST00000445658.6 ) ERBB2 p.Gly778_Pro780dup (p.G778_P780dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Phase 2 trial of ERBB-inhibitor dacomitinib in sta... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | false | CIViC Evidence | detail |
| Phase 2 trial of ERBB-inhibitor dacomitinib in sta... | ERBB2 |
ERBB2 p.Gly778_Pro780dup (p.G778_P780dup) ( ENST00000584450.5, ENST00000406381.6, ENST00000584601.5, ENST00000541774.5, ENST00000269571.10, ENST00000445658.6 ) ERBB2 p.Gly778_Pro780dup (p.G778_P780dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Phase 2 trial of ERBB-inhibitor dacomitinib in sta... | ERBB2 |
ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000541774.5, ENST00000269571.10, ENST00000445658.6, ENST00000406381.6, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | false | CIViC Evidence | detail |
| Phase 2 trial of ERBB-inhibitor dacomitinib in sta... | ERBB2 |
ERBB2 p.Met774delinsTrpLeuVal (p.M774delinsWLV) ( ENST00000584601.5, ENST00000269571.10, ENST00000584450.5, ENST00000445658.6, ENST00000406381.6, ENST00000541774.5 ) ERBB2 p.Met774delinsTrpLeuVal (p.M774delinsWLV) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study using NCI-H322 cells (wildtyp... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In Lung Cancer patients with acquired resistance t... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study using NCI-H322 cells (wildtyp... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Non-small cell cancer patients from two studies [T... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| The authors pooled patients with exon 19 deletion ... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In the ARCHER 1050 Phase 3 Trial (NCT01774721), 45... | EGFR | EGFR MUTATION EGFR MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In this preclinical study, the EGFR inhibitor daco... | PTEN | PTEN EXPRESSION PTEN EXPRESSION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT04609319 | Active, not recruiting | Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review | January 23, 2021 | October 8, 2024 | |
| NCT03810807 | Active, not recruiting | Phase 1 | Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer | January 17, 2019 | January 2025 |
| NCT04027647 | Active, not recruiting | Phase 2 | Phase 2 Study of Dacomitinib in NSCLC | September 11, 2019 | March 31, 2026 |
| NCT01737008 | Completed | Phase 1 | Dacomitinib Plus Radiotherapy, With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck | January 2013 | May 2015 |
| NCT01858389 | Completed | Phase 2 | A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer | July 2013 | September 2015 |
| NCT01920061 | Completed | Phase 1 | A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC) | September 10, 2013 | January 8, 2020 |
| NCT02097433 | Completed | Phase 1 | Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers | July 2014 | September 2014 |
| NCT02382796 | Completed | Phase 2 | A Rollover Protocol of Dacomitinib For Patients In Japan | July 10, 2015 | May 30, 2019 |
| NCT01465802 | Completed | Phase 2 | Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO | December 26, 2011 | May 18, 2015 |
| NCT01571388 | Completed | Phase 1 | A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment | April 2012 | August 2012 |
| NCT01728233 | Completed | Phase 2 | Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis | June 15, 2013 | September 21, 2018 |
| NCT03755102 | Completed | Early Phase 1 | A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib. | November 21, 2018 | July 7, 2023 |
| NCT03865446 | Completed | Phase 1 | Evaluate Severe Hepatic Impairment on Dacomitinib PK | April 5, 2019 | October 24, 2019 |
| NCT04511533 | Completed | Phase 4 | Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations | August 27, 2020 | November 8, 2022 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT05834348 | Recruiting | A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. | June 26, 2023 | February 3, 2025 | |
| NCT04768491 | Recruiting | Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC | September 1, 2020 | October 31, 2024 | |
| NCT04811001 | Recruiting | Phase 2 | Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations | June 12, 2020 | December 31, 2023 |
| NCT05271916 | Recruiting | Phase 1/Phase 2 | First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations | October 13, 2022 | May 1, 2027 |
| NCT02047747 | Terminated | Phase 2 | A Phase II Study of Dacomitinib in Progressive Brain Metastases | February 2014 | February 2016 |
| NCT03878524 | Terminated | Phase 1 | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | April 1, 2020 | December 10, 2020 |
| NCT02268747 | Unknown status | Phase 2 | Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer | November 2014 | November 2016 |
| NCT04339829 | Unknown status | Phase 2 | An Open Label, Multicenter, Phase II Study of Dacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases | August 1, 2020 | August 30, 2023 |
| NCT04504071 | Unknown status | Phase 2 | Dacomitinib in Lung Cancer With Uncommon EGFR Mutations | December 8, 2020 | December 2022 |
| NCT04575415 | Unknown status | Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study | October 7, 2020 | December 2023 | |
| NCT02039336 | Unknown status | Phase 1/Phase 2 | Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC | January 2014 | December 2019 |
| NCT04675008 | Unknown status | Phase 2 | Central Nervous System(CNS) Efficacy of Dacomitinib | December 7, 2020 | March 1, 2023 |
- Target (Drug list of Screening Committee of Anticancer Drugs)
- EGFR/Her2
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- PF-00299804