Clinical Trials

Several Phase I and Phase II clinical trials have evaluated AT9283 across adult and pediatric solid tumors as well as various hematologic malignancies, including multiple myeloma, non-Hodgkin's lymphoma, acute and chronic myeloid leukemias, myelodysplastic syndromes, and myelofibrosis. Sponsored by entities such as Astex Pharmaceuticals Inc., the Canadian Cancer Trials Group, and Cancer Research UK, these evaluations assessed safety, tolerability, and initial efficacy. Across these clinical trials, most studies are completed, while others were terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00985868 COMPLETED
Unspecified Childhood Solid Tumor, Protocol Specific
Cancer Research UK
2009-09 PHASE1
NCT01145989 COMPLETED
Multiple Myeloma
NCIC Clinical Trials Group
2011-02-15 PHASE2
NCT01431664 COMPLETED
Leukemia
Cancer Research UK
2011-09 PHASE1
NCT01145989 Completed
Multiple Myeloma
NCIC Clinical Trials Group|Astex Pharmaceuticals Inc.|Canadian Cancer Trials Group
2011-02-15 Phase 2
NCT00443976 COMPLETED
Non-Hodgkins Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
NCIC Clinical Trials Group
2007-01-30 PHASE1
NCT00522990 TERMINATED
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndromes; Myelofibrosis
Astex Pharmaceuticals, Inc.
2006-09 PHASE1; PHASE2
NCT00443976 Completed
Non-Hodgkins Lymphoma|Unspecified Adult Solid Tumor Protocol Specific
NCIC Clinical Trials Group|Astex Pharmaceuticals Inc.|Canadian Cancer Trials Group
2007-01-30 Phase 1

(data from https://clinicaltrials.gov, updated on 2019-11-29)

Check the AT9283 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AT9283 potently binds to and inhibits multi-kinase targets including JAK2, JAK3, Aurora A/B, and BCR-ABL, thereby blocking downstream substrate phosphorylation such as STAT5 signal transduction and serine-10 histone H3 modification. This inhibition induces endoreduplication, impairs mitotic progression, and suppresses cellular proliferation, leading to tumor growth inhibition relevant to the clinical treatment of hematologic malignancies such as leukemia and multiple myeloma as well as 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>).

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