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Overview

This partially randomized phase I trial studies the side effects and how well sequential dosing of vascular endothelial growth factor receptor (VEGFR)/platelet derived growth factor receptor (PDGFR) dual kinase inhibitor X-82 and docetaxel works in treating patients with solid tumors. VEGFR/PDGFR dual kinase inhibitor X-82 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving VEGFR/PDGFR dual kinase inhibitor X-82 and docetaxel one at a time instead of concurrently may work in treating patients with solid tumors.

Start Date01 Sep 2014

Sponsor / Collaborator

University of Wisconsin Madison

[+1]

NCT01784861 / TerminatedPhase 1/2IIT

A Phase I/II Study of X-82, an Oral Anti-VEGFR Tyrosine Kinase Inhibitor, With Everolimus for Patients With Pancreatic Neuroendocrine Tumors

This study is to evaluate the combination of an investigational drug X-82 with everolimus in the treatment of pancreatic neuroendocrine tumors.

Start Date03 May 2013

Sponsor / Collaborator

Washington University School of Medicine

[+1]

100 Clinical Results associated with Tyrogenex, Inc.

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0 Patents (Medical) associated with Tyrogenex, Inc.

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4

Literatures (Medical) associated with Tyrogenex, Inc.

01 May 2021·British Journal of OphthalmologyQ2 · MEDICINE

APEX: a phase II randomised clinical trial evaluating the safety and preliminary efficacy of oral X-82 to treat exudative age-related macular degeneration

Q2 · MEDICINE

Article

Author: O'Shaughnessy, Denis ; Cohen, Michael N ; Awh, Carl C ; Rosenfeld, Philip ; Heier, Jeffrey S ; Fisher, Kate ; Salazar, Daniel E ; Cerami, Jennifer

PurposeThe safety and efficacy of X-82, an orally administered inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor, was investigated for treatment of wet age-related macular degeneration (AMD) in a phase II clinical trial.MethodsThis phase II, randomised, double-masked, placebo-controlled trial enrolled subjects with a prior diagnosis of exudative AMD having received at least two intravitreal injections of anti-VEGF therapy. Subjects were randomised equally into four groups that received either daily 50mg, 100mg or 200mg dosages of X-82 or a placebo tablet. At each 4-week interval visit for 52 weeks, subjects were to be assessed to determine if rescue treatment was needed with anti-VEGF therapy.Results157 patients were enrolled. Due to gastrointestinal and hepatobiliary adverse events and the fulfilment of the primary endpoint, the trial was stopped prematurely after a second interim analysis. The primary endpoint of non-inferiority of visual acuity compared with placebo was demonstrated in all groups receiving X-82 (p<0.001). There was a dose-dependent trend in the number of injections over a 52-week period, with the 50 mg (n=40), 100 mg (n=39), 200 mg (n=39) and placebo (n=39) group requiring 6.7, 6.0, 4.7 and 8.1 injections, respectively.ConclusionsX-82 oral therapy in combination withpro re nataanti-VEGF injections showed non-inferiority in visual acuity outcomes while achieving a dose-dependent decrease in the number of anti-VEGF injections compared with placebo. Given the limited tolerability and safety issues observed, X-82 does not have a sufficient benefit to risk profile in treatment of patients with AMD.

20 May 2016·Journal of Clinical Oncology

Phase I study of X-82, an oral dual anti-VEGFR/PDGFR tyrosine kinase inhibitor, with everolimus in solid tumors.

Author: Tan, Benjamin R. ; Morton, Ashley ; Chan, Emily ; Liang, Chris ; Roth, Bruce J. ; Picus, Joel ; Lockhart, Albert C. ; Wang-Gillam, Andrea

2588Background: Anti-VEGFR tyrosine kinase inhibitors(TKI), combined with mTOR inhibitors, such as everolimus resulted in a significant response and progression-free survival benefit in pts with renal cell carcinoma. [Motzer]. In 2 Phase I studies of everolimus combined with sunitinib or lenvantinib, daily doses of everolimus above 2.5 mg and 5 mg, respectively, were not tolerated. [Molina]. X-82 is an oral multikinase inhibitor targeting VEGFR and PDGFR with a shorter half-life and limited tissue accumulation, thus, X-82 can potentially be combined with full therapeutic doses of everolimus. Methods: A 3+3 dose escalation design was utilized to determine the dose-limiting toxicities (DLT) and the recommended Phase II dose (RP2D) of daily oral X82 plus everolimus at 10 mg PO daily for patients with solid malignancies. Eligibility include PS 0-1, measurable disease, adequate organ function and normal LVEF. Results: 21 pts (10 M/ 11F) with various malignancies were enrolled. 3 pts were not evaluable for DLT:...

20 May 2016·Journal of Clinical Oncology

Plasma genotyping of patients enrolled on the expansion phase I/II trial of X-396 in patients (pts) with ALK+ non-small cell lung cancer (NSCLC).

Author: Waqar, Saiama Naheed ; Gockerman, Jon P ; Wakelee, Heather A. ; Carter, Corey Allan ; Hernandez, Jennifer ; Dukart, Gary ; Reckamp, Karen L. ; Neal, Joel W. ; Harrow, Kimberly ; Lovly, Christine Marie ; Horn, Leora ; Liang, Chris ; Infante, Jeffrey R. ; Gibbons, James J. ; Newman-Eerkes, Tara ; Lim, Lee ; Blumenschein, George R.

9056Background: X-396 is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. We...

100 Deals associated with Tyrogenex, Inc.

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100 Translational Medicine associated with Tyrogenex, Inc.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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