Clinical Trials

Multiple clinical trials have evaluated tandutinib (MLN518) as monotherapy and in combination regimens across Phase 1, Phase 2, and combined Phase 1/2 studies sponsored primarily by Millennium Pharmaceuticals Inc. and the National Cancer Institute. These studies targeted advanced malignancies, including acute myelogenous leukemia, recurrent glioblastoma and high-grade gliomas, metastatic clear cell renal cell carcinoma, and androgen-independent prostate cancer. Recruitment has concluded across all studies, with individual trials designated as either completed or withdrawn prior to completion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00379080 COMPLETED
Adult Brain Tumor; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
National Cancer Institute (NCI)
 2007-01 PHASE1; PHASE2
NCT00667394 COMPLETED
Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Mixed Oligoastrocytoma
National Cancer Institute (NCI)
 2008-04 PHASE2
NCT00904852 WITHDRAWN
Glioblastoma Multiforme
Millennium Pharmaceuticals, Inc.
 2009-06 PHASE1
NCT00390468 COMPLETED
Metastatic Cancer; Pain; Prostate Cancer
National Cancer Institute (NCI)
 2006-10 PHASE2
NCT00904852 Withdrawn
Glioblastoma Multiforme
Millennium Pharmaceuticals Inc.
 2009-06 Phase 1
NCT00408902 COMPLETED
Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer
National Cancer Institute (NCI)
 2006-11 PHASE2
NCT00274248 COMPLETED
Acute Myelogenous Leukemia
Millennium Pharmaceuticals, Inc.
 2005-03 PHASE1
NCT00297921 WITHDRAWN
Acute Myelogenous Leukemia
Millennium Pharmaceuticals, Inc.
 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2017-04-07)

Check the Tandutinib (MLN518) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tandutinib functions as a potent antagonist of receptor tyrosine kinases, specifically targeting FLT3, PDGFR, and c-Kit. By inhibiting receptor autophosphorylation and suppressing downstream signal transduction, it halts cytokine-independent cell proliferation and induces apoptosis in receptor-driven malignant cells, forming the biochemical rationale for its investigation in clinical trials targeting acute myelogenous leukemia, glioblastoma, and renal cell carcinoma.

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.