MK-8776 (SCH 900776) Clinical Trials

Size	Price	Qty
5mg	USD 210
50mg	USD 970

Clinical Trials

Multiple Phase I and Phase II clinical trials have evaluated MK-8776 (SCH 900776) in conditions including advanced solid tumors, non-Hodgkin lymphoma, Hodgkin disease, and adult acute myeloid leukemia. Sponsored by pharmaceutical industry leaders, national research organizations, and academic institutions, these studies include completed, terminated, and withdrawn trials. Completed trials focused on combination regimens with chemotherapeutic agents such as gemcitabine or cytarabine.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01870596	COMPLETED	Adult Acute Megakaryoblastic Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Recurrent Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2013-05	PHASE2
NCT01521299	WITHDRAWN	Advanced Solid Tumors	Dartmouth-Hitchcock Medical Center	2012-03	PHASE1
NCT00907517	TERMINATED	Myelogenous Leukemia, Acute; Leukemia, Lymphocytic, Acute; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive; Myelogenous Leukemia, Chronic, Aggressive Phase	Merck Sharp & Dohme LLC	2009-07-29	PHASE1
NCT00779584	COMPLETED	Hodgkin Disease; Lymphoma, Non-Hodgkin; Neoplasms	Merck Sharp & Dohme LLC	2008-10-17	PHASE1
NCT00779584	Completed	Hodgkin Disease\|Lymphoma Non-Hodgkin\|Neoplasms	Merck Sharp & Dohme LLC	2008-10-17	Phase 1

(data from https://clinicaltrials.gov, updated on 2016-09-01)

Check the MK-8776 (SCH 900776) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-8776 selectively binds to cell cycle checkpoint kinase 1 (CHK1), inhibiting its enzymatic activity and disrupting DNA damage response signaling pathways required for replication fork stability. This inhibition prevents DNA repair and cell cycle arrest following DNA damage, promoting premature mitotic entry and apoptosis in tumor cells evaluated in clinical studies for acute leukemias and advanced solid tumors.

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>).