NCT02393248 — drugset

Summary

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

Timeline

Start: 2015-02-27
Primary completion: 2021-12-17
Completion: 2021-12-17

Publications

Subbiah V, Iannotti NO, Gutierrez M, Smith DC, Feliz L, Lihou CF, Tian C, Silverman IM, Ji T, Saleh M. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Ann Oncol. 2022 May;33(5):522-533. doi: 10.1016/j.annonc.2022.02.001. Epub 2022 Feb 14.
Gong X, Ji T, Liu X, Chen X, Yeleswaram S. Evaluation of the clinical cardiac safety of pemigatinib, a fibroblast growth factor receptor inhibitor, in participants with advanced malignancies. Pharmacol Res Perspect. 2022 Feb;10(1):e00906. doi: 10.1002/prp2.906.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Pemigatinib	Small molecule	1 mg	Oral
Subject	Pemigatinib	Small molecule	2 mg	Oral
Subject	Pemigatinib	Small molecule	4 mg	Oral
Subject	Pemigatinib	Small molecule	6 mg	Oral
Subject	Pemigatinib	Small molecule	7.5 mg	Oral
Subject	Pemigatinib	Small molecule	9 mg	Oral
Subject	Pemigatinib	Small molecule	10 mg	Oral
Subject	Pemigatinib	Small molecule	13.5 mg	Oral
Subject	Pemigatinib	Small molecule	20 mg	Oral
Subject	Retifanlimab	Monoclonal antibody	500 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Summary

Timeline

Publications

Drugs

Indications