Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 2, Phase 3, and combined Phase 2/3 stages have evaluated Fosbretabulin for solid tumors and vascular conditions, including platinum-resistant ovarian cancer, anaplastic thyroid cancer, neuroendocrine tumors, head and neck cancer, and polypoidal choroidal vasculopathy. Sponsored by pharmaceutical entities such as Mateon Therapeutics alongside academic institutions like Case Comprehensive Cancer Center and the National Cancer Institute, these investigations display mixed outcomes featuring completed, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03014297 TERMINATED
Neuroendocrine Tumors; Everolimus
Lowell Anthony, MD
 2017-03-06 PHASE1
NCT02055690 TERMINATED
Ovarian Neoplasms; Neoplasms, Ovarian; Ovarian Cancer
The Christie NHS Foundation Trust
 2014-09 PHASE1; PHASE2
NCT02641639 TERMINATED
Platinum Resistant Ovarian Cancer
Mateon Therapeutics
 2016-06 PHASE2; PHASE3
NCT01701349 WITHDRAWN
Anaplastic Thyroid Cancer
Mateon Therapeutics
 2015-03 PHASE3
NCT01305213 COMPLETED
Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
National Cancer Institute (NCI)
 2011-03-21 PHASE2
NCT02279602 COMPLETED
Neuroendocrine Tumors
Mateon Therapeutics
 2014-12 PHASE2
NCT02132468 COMPLETED
Neuroendocrine Tumors
Mateon Therapeutics
 2014-09 PHASE2
NCT02641639 Terminated
Platinum Resistant Ovarian Cancer
Mateon Therapeutics
 2016-06 Phase 2|Phase 3
NCT02055690 Terminated
Ovarian Neoplasms|Neoplasms Ovarian|Ovarian Cancer
The Christie NHS Foundation Trust|Novartis|Mateon Therapeutics|East and North Hertfordshire NHS Trust
 2014-09 Phase 1|Phase 2
NCT00653939 COMPLETED
Tumors
Mateon Therapeutics
 2008-03 PHASE2
NCT01023295 COMPLETED
Polypoidal Choroidal Vasculopathy
Mateon Therapeutics
 2009-07 PHASE2
NCT01023295 Completed
Polypoidal Choroidal Vasculopathy
Mateon Therapeutics
 2009-07 Phase 2
NCT00060242 COMPLETED
Head and Neck Cancer
Case Comprehensive Cancer Center
 2003-02 PHASE2
NCT00077103 TERMINATED
Head and Neck Cancer
Case Comprehensive Cancer Center
 2003-11 PHASE1; PHASE2
NCT00003768 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Case Comprehensive Cancer Center
 1998-09 PHASE1
NCT00003698 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
University of Glasgow
 1998-07 PHASE1
NCT01052363 WITHDRAWN
Central Nervous System Tumors
West Virginia University
 2010-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2019-08-08)

Check the Fosbretabulin (Combretastatin A4 Phosphate) Disodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fosbretabulin acts as a water-soluble prodrug that releases Combretastatin A4 to bind β-tubulin, thereby inhibiting tubulin polymerization and disrupting microtubule dynamics. This inhibition triggers mitotic arrest and apoptosis in vascular endothelial cells, resulting in selective tumor vessel disruption and therapeutic anti-tumor activity in conditions such as platinum-resistant ovarian cancer and neuroendocrine tumors.

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.