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.
Mechanism and Biochemical Profile
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.