Clinical Trials

Several Phase I and Phase II clinical trials have evaluated the oral therapeutic agent ENMD-2076 in advanced solid tumors and hematological malignancies, including multiple myeloma, ovarian clear cell carcinoma, platinum-resistant ovarian cancer, soft tissue sarcoma, triple-negative breast cancer, and hepatocellular carcinoma. Sponsored by entities such as CASI Pharmaceuticals Inc. and the University Health Network, Toronto, these studies have all reached completed recruitment status. Overall, the clinical landscape reflects significant evaluation of ENMD-2076 across diverse hyperproliferative conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02234986 COMPLETED
Advanced Adult Hepatocellular Carcinoma; Advanced Fibrolamellar Carcinoma
CASI pharmaceuticals, Inc.
 2015-10 PHASE2
NCT01639248 COMPLETED
Triple Negative Breast Cancer
CASI pharmaceuticals, Inc.
 2012-07 PHASE2
NCT01914510 COMPLETED
Ovarian Clear Cell Carcinoma
University Health Network, Toronto
 2013-09 PHASE2
NCT01719744 COMPLETED
Advanced; Metastatic; Soft Tissue Sarcoma
University Health Network, Toronto
 2013-01 PHASE2
NCT00806065 COMPLETED
Multiple Myeloma
CASI pharmaceuticals, Inc.
 2008-12 PHASE1
NCT01104675 COMPLETED
Ovarian Cancer; Fallopian Cancer; Peritoneal Cancer
CASI pharmaceuticals, Inc.
 2010-04 PHASE2
NCT00904787 COMPLETED
Relapsed or Refractory Hematological Malignancies
CASI pharmaceuticals, Inc.
 2009-04 PHASE1
NCT00658671 COMPLETED
Advanced Cancer
CASI pharmaceuticals, Inc.
 2008-04 PHASE1
NCT00904787 Completed
Relapsed or Refractory Hematological Malignancies
CASI Pharmaceuticals Inc.
 2009-04 Phase 1
NCT00806065 Completed
Multiple Myeloma
CASI Pharmaceuticals Inc.
 2008-12 Phase 1
NCT00658671 Completed
Advanced Cancer
CASI Pharmaceuticals Inc.
 2008-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-04-18)

Check the ENMD-2076 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ENMD-2076 is an orally bioavailable multi-kinase inhibitor that selectively targets Aurora A kinase and Flt3 while also inhibiting VEGFR2/KDR, Src, and FGFR1, thereby suppressing downstream oncogenic signaling pathways critical for vascular endothelial growth and mitotic progression. This inhibition induces G2/M cell cycle arrest and triggers apoptosis in tumor cells, providing the biological rationale for its clinical evaluation in conditions such as triple-negative breast cancer, ovarian cancer, and hematological malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.