Drugs / INCB7839

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed US (FDA) — solid adenocarcinoma with mucin production 2004-12-28

“We filed the IND for our oral sheddase inhibitor, INCB7839, on December 28.” incyte.com ↗

Trials 2

2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04295759 Jul 2020 → Dec 2023 anaplastic astrocytoma, anaplastic oligodendroglioma, diffuse intrinsic pontine glioma, glioblastoma Pediatric Brain Tumor Consortium Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02141451 May 2014 → Jan 2019 diffuse large B-cell lymphoma Masonic Cancer Center, University of Minnesota Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2010-06-06 Incyte Corporation Results Results from an Ongoing Phase I/II Trial of Oral INCB7839 Presented at ASCO incyte.com ↗
Data suggest that treatment with INCB7839 in combination with trastuzumab provides improved clinical responses in a subset of metastaticbreast cancer patients with p95HER2
2009-12-12 Incyte Corporation Results Data from a Phase I/II Study Presented at the 32nd San Antonio Breast Cancer Symposium Suggest that INCB7839 in Combination with Trastuzumab May Improve Clinical Response Rates in HER2 Positive Patients with Advanced Metastatic Disease incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced today positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 46 patients with HER2 positive metastatic breast cancer.
2007-12-16 Incyte Corporation Results Data Presented at the 30th San Antonio Breast Cancer Symposium Supports Further Development of INCB7839 as a New Oral Treatment for Breast Cancer incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced today that three scientific posters have been presented at the 30th San Antonio Breast Cancer Symposium describing the potential benefits of its selective sheddase inhibitor, INCB7839, in the treatment of metastatic breast cancer.
2005-04-06 Incyte Corporation Regulatory Incyte Begins Phase I Study in Healthy Volunteers of Novel Oral Cancer Compound, INCB7839 incyte.com ↗
Incyte Corporation (Nasdaq:INCY) today announced that it has initiated a Phase I clinical trial of INCB7839, a novel orally-available sheddase inhibitor that is being developed as a treatment for solid tumors.

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as INCB7839 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02141451 ↗
1

NCT04295759 ↗

Action Inhibit “using an ADAM17 inhibitor (INCB7839) with rituximab as consolidation therapy” NCT02141451 ↗
Route Oral “INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2.” NCT04295759 ↗
Target ADAM17 “using an ADAM17 inhibitor (INCB7839) with rituximab as consolidation therapy” NCT02141451 ↗