Clinical Trials

Linifanib (ABT-869) has been evaluated in multiple Phase 1, Phase 2, and Phase 3 clinical trials targeting solid tumors, including advanced non-small cell lung cancer, hepatocellular carcinoma, recurrent colorectal carcinoma, and endometriosis. Sponsored by pharmaceutical entities and academic research institutes, these studies investigated drug interactions, pharmacokinetics, and therapeutic efficacy. The broader clinical program reflects varying recruitment statuses, encompassing completed, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03481842 WITHDRAWN
Endometriosis; Endometriosis Ovary; Endometriosis Externa; Endometriosis, Rectum
BioGene Pharmaceutical Ltd.
 2021-10-10 PHASE1; PHASE2
NCT01286974 TERMINATED
Advanced Solid Tumors
Abbott
 2011-08 PHASE1
NCT01009593 TERMINATED
Hepatocellular Carcinoma Non-resectable; Hepatocellular Carcinoma Recurrent; Carcinoma, Hepatocellular; Liver Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Carcinoma; Liver Neoplasms; Neoplasms; Neoplasms by Site; Digestive System Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial
Abbott
 2010-01 PHASE3
NCT01225302 COMPLETED
Non-Small Cell Lung Cancer
AbbVie
 2010-09 PHASE1
NCT01413893 COMPLETED
Advanced Solid Tumors
AbbVie
 2011-06 PHASE1
NCT00733187 COMPLETED
Advanced Solid Tumors
AbbVie (prior sponsor, Abbott)
 2009-02 PHASE1
NCT00718380 COMPLETED
Solid Tumor
AbbVie
 2008-09 PHASE1
NCT01365910 TERMINATED
Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer
Vanderbilt-Ingram Cancer Center
 2011-06 PHASE2
NCT00707889 COMPLETED
Advanced Colorectal Cancer; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum
AbbVie (prior sponsor, Abbott)
 2008-10 PHASE2
NCT00716534 COMPLETED
Advanced or Metastatic Non-Small Cell Lung Cancer
AbbVie (prior sponsor, Abbott)
 2008-06 PHASE2
NCT01506934 TERMINATED
Advanced or Metastatic Solid Tumors
Abbott
 2011-10 PHASE1
NCT01381341 COMPLETED
Advanced Solid Tumors
Abbott
 2011-05 PHASE1
NCT01401933 COMPLETED
Advanced Solid Tumors
Abbott
 2011-05 PHASE1
NCT01401933 COMPLETED
Advanced Solid Tumors
Abbott
 2011-05 PHASE1
NCT00517920 COMPLETED
Advanced Hepatocellular Carcinoma
AbbVie (prior sponsor, Abbott)
 2007-09 PHASE2
NCT00517790 COMPLETED
Non-Small Cell Lung Cancer (NSCLC)
AbbVie (prior sponsor, Abbott)
 2007-08 PHASE2
NCT00486538 COMPLETED
Advanced Renal Cell Carcinoma
AbbVie (prior sponsor, Abbott)
 2007-06 PHASE2
NCT01401933 Completed
Advanced Solid Tumors
Abbott
 2011-05 Phase 1
NCT01381341 Completed
Advanced Solid Tumors
Abbott
 2011-05 Phase 1
NCT01114191 COMPLETED
Solid Tumors
Abbott
 2010-05 PHASE1
NCT01114191 COMPLETED
Solid Tumors
Abbott
 2010-05 PHASE1
NCT01114191 Completed
Solid Tumors
Abbott
 2010-05 Phase 1
NCT00645177 COMPLETED
Metastatic Breast Cancer
AbbVie (prior sponsor, Abbott)
 2008-07 PHASE2
NCT00754104 WITHDRAWN
Solid Tumors
Abbott
 2008-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2021-10-29)

Check the Linifanib (ABT-869) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Linifanib functions as a potent, ATP-competitive inhibitor of vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) tyrosine kinase families, effectively blocking downstream pro-survival and angiogenic signaling pathways to induce tumor cell apoptosis and suppress cell proliferation. This targeted receptor tyrosine kinase inhibition impairs tumor neovascularization and cell survival, providing a therapeutic rationale for its clinical evaluation in advanced solid tumors, hepatocellular carcinoma, 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.