Clinical Trials

MK-0752 has been evaluated in multiple Phase 1, Phase 2, and Phase 4 clinical trials involving healthy volunteers and patients with advanced solid tumors, central nervous system malignancies, acute T-cell lymphoblastic leukemia, pancreatic cancer, and metastatic breast cancer. Supported by industry sponsors like Merck Sharp & Dohme LLC alongside academic institutions such as Cancer Research UK and the Pediatric Brain Tumor Consortium, these protocols comprise both completed and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01098344 COMPLETED
Pancreatic Cancer
Cancer Research UK
2010-04 PHASE1
NCT01295632 COMPLETED
Advanced Cancer
Merck Sharp & Dohme LLC
2011-02 PHASE1
NCT01243762 TERMINATED
Neoplasms Malignant
Merck Sharp & Dohme LLC
2010-11-22 PHASE1
NCT00756717 COMPLETED
Breast Cancer
Loyola University
2008-02-14 PHASE4
NCT00106145 COMPLETED
Advanced Breast Cancer; Other Solid Tumors
Merck Sharp & Dohme LLC
2005-04 PHASE1
NCT01295632 Completed
Advanced Cancer
Merck Sharp & Dohme LLC
2011-02 Phase 1
NCT00572182 TERMINATED
Brain and Central Nervous System Tumors
Pediatric Brain Tumor Consortium
2008-07 PHASE1
NCT00645333 COMPLETED
Metastatic Breast Cancer
University of Michigan Rogel Cancer Center
2008-03 PHASE1; PHASE2
NCT00803894 COMPLETED
Healthy
Merck Sharp & Dohme LLC
2008-12 PHASE1
NCT00572182 Terminated
Brain and Central Nervous System Tumors
Pediatric Brain Tumor Consortium|National Cancer Institute (NCI)
2008-07 Phase 1
NCT00100152 TERMINATED
Leukemia, Lymphoblastic, Acute, T-cell; Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Myelodysplastic Syndromes
Merck Sharp & Dohme LLC
2005-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2015-10-14)

Check the MK-0752 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-0752 selectively binds to and inhibits γ-secretase, thereby blocking the downstream proteolytic cleavage of Notch transmembrane receptors and amyloid precursor protein. This inhibition suppresses oncogenic Notch signaling pathways to attenuate cellular proliferation, which directly provides the rationale for its clinical investigation in solid tumors, pancreatic cancer, and leukemia.

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>).

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