Clinical Trials

Multiple clinical trials have evaluated lucitanib across Phase 1/2 and Phase 2 studies for advanced malignancies, including solid tumors, gynecologic cancers, FGF-aberrant metastatic breast cancer, and lung cancer. Spearheaded by industry sponsors Clovis Oncology and Bristol-Myers Squibb alongside academic partners such as the European Network of Gynaecological Oncological Trial Groups and the University of California San Diego, these investigations are currently reported as terminated, suspended, or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04042116 Suspended
Advanced Solid Tumor|Gynecologic Cancer
Clovis Oncology Inc.|Bristol-Myers Squibb|European Network of Gynaecological Oncological Trial Groups (ENGOT)
 2019-07-29 Phase 1|Phase 2
NCT02747797 Withdrawn
Advanced Cancer
Teresa Helsten MD|Clovis Oncology Inc.|University of California San Diego
 2017-04 Phase 2
NCT02202746 Terminated
Breast Cancer|Metastatic Breast Cancer|MBC|HER2 Positive|HER2|Estrogen Receptor Positive|ER|Triple Negative
Clovis Oncology Inc.
 2014-09-09 Phase 2
NCT02109016 Terminated
Non-Small Cell Lung Cancer|Squamous Non-Small Cell Lung Cancer|NSCLC|Small Cell Lung Cancer|SCLC|Lung Cancer|Advanced Lung Cancer|Metastatic Lung Cancer|Stage IV Lung Cancer
Clovis Oncology Inc.
 2014-04 Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Lucitanib (E3810) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lucitanib hydrochloride acts as a potent dual receptor tyrosine kinase inhibitor that selectively binds to VEGFR1–3 and FGFR1–2, thereby blocking downstream pro-angiogenic and proliferative signal transduction pathways to inhibit vascular endothelial and tumor cell proliferation. By simultaneously suppressing tumor angiogenesis and FGFR-mediated oncogenic signaling, this compound aims to disrupt tumor vascularization and cell survival in clinical settings such as advanced solid tumors, metastatic breast 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.