Clinical Trials

A clinical trial investigated novel dosing schedules of the oral antineoplastic agent Indibulin in patients with metastatic breast cancer. Spanning Phase 1 and Phase 2 to evaluate preliminary safety and efficacy, the study was jointly sponsored by Alaunos Therapeutics and Memorial Sloan Kettering Cancer Center. The trial's recruitment status is currently listed as unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01113970 Unknown status
Metastatic Breast Cancer
Alaunos Therapeutics|Memorial Sloan Kettering Cancer Center
 2010-03 Phase 1|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indibulin binds directly to tubulin to inhibit microtubule assembly, thereby disrupting mitotic spindle dynamics and arresting dividing cells in the M-phase of the cell cycle. This persistent mitotic arrest triggers apoptotic cell death pathways, ultimately inhibiting tumor progression in therapeutic settings such as metastatic breast 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.