Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, sponsored primarily by AstraZeneca alongside academic institutions such as University College London and UNICANCER, have evaluated Sapitinib (AZD8931). These studies investigated conditions including early and metastatic breast, metastatic gastric or gastro-esophageal junction, metastatic colorectal, and non-small cell lung cancers, advanced solid malignancies, and pharmacokinetics in healthy volunteers. Recruitment statuses across these trials include completed, active not recruiting, and terminated, with early-phase safety trials reaching completion while several Phase 2 combination trials were terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02299999 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
UNICANCER
 2014-04-07 PHASE2
NCT01862003 COMPLETED
Metastatic Colorectal Cancer; Recurrent Colorectal Cancer
University College, London
 2014-05 PHASE2
NCT02117167 COMPLETED
Non-small Cell Lung Cancer Metastatic
UNICANCER
 2014-04-23 PHASE2
NCT01579578 TERMINATED
Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
AstraZeneca
 2012-04 PHASE2
NCT01596530 TERMINATED
Breast Neoplasm
AstraZeneca
 2012-06 PHASE1
NCT01151215 TERMINATED
Neoplasms; Breast Neoplasms; Breast Cancer
AstraZeneca
 2010-06 PHASE2
NCT01596530 Terminated
Breast Neoplasm
AstraZeneca
 2012-06 Phase 1
NCT01579578 Terminated
Metastatic Gastric or Gastro-oesophageal Junction Cancer
AstraZeneca
 2012-04 Phase 2
NCT01003158 COMPLETED
Neoplasms; Metastatic Cancer; Breast Cancer
AstraZeneca
 2009-10 PHASE1
NCT00900627 COMPLETED
Neoplasms; Breast Neoplasms; Breast Cancer
AstraZeneca
 2009-06 PHASE1; PHASE2
NCT01330758 COMPLETED
Healthy
AstraZeneca
 2011-04 PHASE1
NCT01284595 COMPLETED
Healthy
AstraZeneca
 2011-03 PHASE1
NCT01330758 Completed
Healthy
AstraZeneca
 2011-04 Phase 1
NCT01284595 Completed
Healthy
AstraZeneca
 2011-03 Phase 1
NCT01151215 Terminated
Neoplasms|Breast Neoplasms|Breast Cancer
AstraZeneca
 2010-06 Phase 2
NCT00637039 COMPLETED
Advanced Solid Malignancies
AstraZeneca
 2008-02 PHASE1
NCT00879346 COMPLETED
Healthy
AstraZeneca
 2009-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-01-15)

Check the Sapitinib (AZD8931) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sapitinib (AZD8931) functions as a reversible, ATP-competitive pan-ErbB inhibitor that binds to EGFR, ErbB2, and ErbB3, suppressing receptor autophosphorylation and blocking downstream pro-survival signaling pathways to induce apoptosis and inhibit cellular proliferation. By broadly disabling ErbB network signaling across target-expressing malignancies, Sapitinib attenuates tumor growth and survival, providing the mechanistic rationale for its clinical evaluation in patients with advanced solid tumors, breast cancer, gastric cancer, and non-small cell lung cancer.

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.