Phase I, Open-Label, Dose-Escalation/Dose-Expansion Study of Lifirafenib (BGB-283), an RAF Family Kinase Inhibitor, in Patients With Solid Tumors.


Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333

Informations de publication

Date de publication:
01 07 2020
Historique:
pubmed: 18 3 2020
medline: 3 2 2021
entrez: 18 3 2020
Statut: ppublish

Résumé

Lifirafenib is an investigational, reversible inhibitor of B-RAF During dose escalation, adult patients with histologically/cytologically confirmed advanced solid tumors received escalating doses of lifirafenib. Primary end points were safety/tolerability during dose escalation and objective response rate in preselected patients with The maximum tolerated dose was established as 40 mg/d; dose-limiting toxicities included reversible thrombocytopenia and nonhematologic toxicity. Across the entire study, the most common grade ≥ 3 treatment-emergent adverse events were hypertension (n = 23; 17.6%) and fatigue (n = 13; 9.9%). One patient with Lifirafenib is a novel inhibitor of key RAF family kinases and EGFR, with an acceptable risk-benefit profile and antitumor activity in patients with

Identifiants

pubmed: 32182156
doi: 10.1200/JCO.19.02654
pmc: PMC7325368
doi:

Substances chimiques

BGB-283 0
Benzimidazoles 0
Naphthyridines 0
Protein Kinase Inhibitors 0

Banques de données

ClinicalTrials.gov
['NCT02610361']

Types de publication

Clinical Trial, Phase I Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2140-2150

Références

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Auteurs

Jayesh Desai (J)

Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Peter MacCallum Cancer Center, Melbourne, Victoria, Australia.

Hui Gan (H)

Olivia Newton-John Cancer Wellness & Research Centre, Austin Hospital, Heidelberg, Victoria, Australia.
La Trobe University School of Cancer Medicine, Heidelberg, Victoria, Australia.
Department of Medicine, University of Melbourne, Heidelberg, Victoria, Australia.

Catherine Barrow (C)

Wellington Hospital, Wellington, New Zealand.

Michael Jameson (M)

Waikato Hospital and University of Auckland Waikato Clinical Campus, Hamilton, New Zealand.

Victoria Atkinson (V)

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.

Andrew Haydon (A)

The Alfred, Melbourne, Victoria, Australia.

Michael Millward (M)

Linear Clinical Research, Nedlands, Western Australia, Australia.

Stephen Begbie (S)

Mid North Coast Cancer Institute, Port Macquarie, New South Wales, Australia.

Michael Brown (M)

Royal Adelaide Hospital, Adelaide, South Australia, Australia.

Ben Markman (B)

Monash Health and Monash University, Clayton, Victoria, Australia.

William Patterson (W)

The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.

Andrew Hill (A)

Tasman Oncology Research, Southport, Queensland, Australia.

Lisa Horvath (L)

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.

Adnan Nagrial (A)

Westmead Hospital, Westmead, New South Wales, Australia.

Gary Richardson (G)

Cabrini Health, Malvern, Victoria, Australia.

Christopher Jackson (C)

Dunedin Hospital, Dunedin, New Zealand.

Michael Friedlander (M)

Prince of Wales Hospital, Randwick, New South Wales, Australia.

Phillip Parente (P)

Eastern Health Monash University, Box Hill Hospital, Box Hill, Victoria, Australia.

Ben Tran (B)

Royal Melbourne Hospital, Melbourne, Victoria, Australia.

Lai Wang (L)

BeiGene (Beijing) Co, Beijing, People's Republic of China.

Yunxin Chen (Y)

BeiGene (Beijing) Co, Beijing, People's Republic of China.

Zhiyu Tang (Z)

BeiGene USA, San Mateo, CA.

Wendy Huang (W)

BeiGene (Beijing) Co, Beijing, People's Republic of China.

John Wu (J)

BeiGene USA, San Mateo, CA.

Dewan Zeng (D)

BeiGene USA, San Mateo, CA.

Lusong Luo (L)

BeiGene (Beijing) Co, Beijing, People's Republic of China.

Benjamin Solomon (B)

Peter MacCallum Cancer Center, Melbourne, Victoria, Australia.

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Classifications MeSH