Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by Amgen have evaluated the small-molecule inhibitor AMG 900 in adult patients with advanced solid tumors, refractory malignancies, and hematologic malignancies including acute myeloid leukemia. These early-phase studies primarily assessed the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics following oral administration. Overall, these clinical trials establish the initial safety and pharmacological profile of AMG 900 across both solid and hematological cancers.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00858377 COMPLETED
Advanced Malignancy; Advanced Solid Tumors; Cancer; Solid Tumors; Tumors
Amgen
 2009-08-10 PHASE1
NCT01380756 COMPLETED
Cancer; Hematologic Malignancies; Leukemia; Myeloid Leukemia
Amgen
 2011-10-04 PHASE1
NCT01380756 Completed
Cancer|Hematologic Malignancies|Leukemia|Myeloid Leukemia
Amgen
 2011-10-04 Phase 1
NCT00858377 Completed
Advanced Malignancy|Advanced Solid Tumors|Cancer|Solid Tumors|Tumors
Amgen
 2009-08-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2019-05-06)

Check the AMG-900 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AMG 900 functions as a potent pan-Aurora kinase inhibitor that selectively binds Aurora A, B, and C, thereby repressing kinase autophosphorylation and blocking downstream histone H3 phosphorylation. This biochemical inhibition disrupts normal mitotic spindle assembly and aborts cell division, inducing endoreduplication and apoptotic cell death in solid tumors and hematologic malignancies.

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>).

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