The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a safe and effective treatment in patients with FLC. Safety will be measured by looking at the adverse events that may happen and the efficacy will look at the progression of the disease over time.

Start Date01 Oct 2015

Sponsor / Collaborator

CASI Pharmaceuticals, Inc.

CTR20150075 / RecruitingPhase 2

一项ENMD-2076治疗局部复发或转移的三阴性乳腺癌晚期患者的安全性和耐受性的IIa期临床试验

[Translation] A Phase IIa clinical trial to evaluate the safety and tolerability of ENMD-2076 in patients with locally recurrent or metastatic advanced triple-negative breast cancer

主要目的：通过三阴性乳腺癌受试者口服一定剂量的ENMD-2076，观察不良事件（AEs）发生的频率和严重程度，评估ENMD-2076的安全性和耐受性，在中国患者人群中确定合适剂量, 进而确定Ⅱb期临床试验治疗剂量。次要目的: 观察肿瘤变化和疾病进展，评价治疗的临床受益率。通过对肿瘤组织标本和血液样品进行基因外显子全序列的分析，评价其与ENMD-2076的药效相关性。

[Translation]

Primary purpose: To observe the frequency and severity of adverse events (AEs) by oral administration of a certain dose of ENMD-2076 to subjects with triple-negative breast cancer, evaluate the safety and tolerability of ENMD-2076, determine the appropriate dose in the Chinese patient population, and then determine the treatment dose for the Phase IIb clinical trial. Secondary purpose: To observe tumor changes and disease progression and evaluate the clinical benefit rate of treatment. By analyzing the full sequence of gene exons in tumor tissue specimens and blood samples, evaluate their correlation with the efficacy of ENMD-2076.

Start Date24 Mar 2015

Sponsor / Collaborator

Alcami Carolinas Corp.

[+2]

NCT01914510 / CompletedPhase 2IIT

Phase II Study of Oral ENMD-2076 Administered to Patients With Ovarian Clear Cell Carcinomas

This is a phase 2 study to see how useful, safe, and tolerable an investigational drug called ENMD-2076 is in treating patients with ovarian clear cell carcinomas.
ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and tyrosine kinase from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A and tyrosine kinase enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.

Start Date01 Sep 2013

Sponsor / Collaborator

University Health Network

100 Clinical Results associated with FGFRs x Aurora A x c-Kit x CSF-1R x FLT3 x VEGFR

100 Translational Medicine associated with FGFRs x Aurora A x c-Kit x CSF-1R x FLT3 x VEGFR

0 Patents (Medical) associated with FGFRs x Aurora A x c-Kit x CSF-1R x FLT3 x VEGFR

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