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A phase 1b/2 study of PF-06747775 as monotherapy or in combination with Palbociclib in patients with epidermal growth factor receptor mutant advanced non-small cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Cho, Byoung Chul | - |
dc.contributor.author | Goldberg, Sarah B. | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Socinski, Mark A. | - |
dc.contributor.author | Burns, Timothy F. | - |
dc.contributor.author | Lwin, Zarnie | - |
dc.contributor.author | Pathan, Nuzhat | - |
dc.contributor.author | Ma, Wei Dong | - |
dc.contributor.author | Masters, Joanna C. | - |
dc.contributor.author | Cossons, Nandini | - |
dc.contributor.author | Wilner, Keith | - |
dc.contributor.author | Nishio, Makoto | - |
dc.contributor.author | Husain, Hatim | - |
dc.date.accessioned | 2022-09-29T03:18:39Z | - |
dc.date.available | 2022-09-29T03:18:39Z | - |
dc.date.created | 2022-07-21 | - |
dc.date.created | 2022-07-21 | - |
dc.date.issued | 2022-07 | - |
dc.identifier.citation | Expert Opinion on Investigational Drugs, Vol.31 No.7, pp.747-757 | - |
dc.identifier.issn | 1354-3784 | - |
dc.identifier.uri | https://hdl.handle.net/10371/184662 | - |
dc.description.abstract | Introduction This Phase 1/2 study (NCT02349633) explored the safety and antitumor activity of PF-06747775 (oral, third-generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor) in patients with advanced non-small cell lung cancer after progression on an EGFR inhibitor. Methods Phase 1 was a dose-escalation study of PF-06747775 monotherapy (starting dose: 25 mg once daily [QD]). Phase 1b/2 evaluated PF-06747775 monotherapy at recommended Phase 2 dose (RP2D; Cohort 1); PF-06747775 200 mg QD plus palbociclib (starting dose: 100 mg QD orally; Cohort 2A); and PF-06747775 monotherapy at RP2D in a Japanese lead-in cohort. Results Sixty-five patients were treated. Median treatment duration was 40.1 weeks. Monotherapy maximum tolerated dose was not determined. Two patients in Cohort 2A had dose-limiting toxicities. The monotherapy RP2D was estimated to be 200 mg QD. Most frequently reported adverse events (AEs) were diarrhea (69.2%), paronychia (69.2%), and rash (60.0%). Most AEs were grades 1-3. Overall, objective response rate (90% confidence interval [CI]) was 41.5% (31.2-52.5%). Median (range) duration of response was 11.09 (2.70-34.57) months. Median progression-free survival (90% CI) was 8.1 (5.4-23.3) months. Conclusions PF-06747775 had a manageable safety profile and the study design highlights important considerations for future anti-EGFR agent development. | - |
dc.language | 영어 | - |
dc.publisher | Ashley Publications Ltd. | - |
dc.title | A phase 1b/2 study of PF-06747775 as monotherapy or in combination with Palbociclib in patients with epidermal growth factor receptor mutant advanced non-small cell lung cancer | - |
dc.type | Article | - |
dc.citation.journaltitle | Expert Opinion on Investigational Drugs | - |
dc.identifier.wosid | 000805736100001 | - |
dc.identifier.scopusid | 2-s2.0-85131566794 | - |
dc.citation.endpage | 757 | - |
dc.citation.number | 7 | - |
dc.citation.startpage | 747 | - |
dc.citation.volume | 31 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | ACQUIRED-RESISTANCE | - |
dc.subject.keywordPlus | NAZARTINIB EGF816 | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | EGFR | - |
dc.subject.keywordPlus | OSIMERTINIB | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | DURVALUMAB | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | MUTATION | - |
dc.subject.keywordAuthor | (5-8) | - |
dc.subject.keywordAuthor | advanced non-small cell lung cancer | - |
dc.subject.keywordAuthor | epidermal growth factor receptor | - |
dc.subject.keywordAuthor | PF-06747775 | - |
dc.subject.keywordAuthor | phase 1 | - |
dc.subject.keywordAuthor | 2 study | - |
dc.subject.keywordAuthor | tyrosine kinase inhibitor | - |
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