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)
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>).