Amifostine trihydrate Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate amifostine trihydrate for its cytoprotective and radioprotective properties across diverse oncological indications, including leukemia, lymphoma, breast cancer, and head and neck malignancies. Sponsored by industry partners and academic medical centers, these studies investigate the mitigation of toxicities such as radiation-induced xerostomia, mucositis, and neurotoxicity, with recruitment statuses ranging from completed to terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00003927	COMPLETED	Breast Cancer	City of Hope Medical Center	1999-05-18	PHASE1
NCT00217438	COMPLETED	Refractory Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma	Fred Hutchinson Cancer Center	2005-07	PHASE3
NCT00040365	COMPLETED	Prostatic Neoplasms	National Cancer Institute (NCI)	2002-06	PHASE2
NCT00503776	TERMINATED	Dysphagia; Head and Neck Cancer; Mucositis; Xerostomia	Vanderbilt-Ingram Cancer Center	2006-01	PHASE2
NCT00058071	COMPLETED	Gestational Trophoblastic Tumor; Neurotoxicity; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific	Gynecologic Oncology Group	2003-03	PHASE3
NCT00003994	COMPLETED	Childhood Hepatoblastoma; Recurrent Childhood Liver Cancer; Stage I Childhood Liver Cancer	Children's Oncology Group	1999-03	PHASE3
NCT00098683	COMPLETED	Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms	Children's Oncology Group	2005-01	PHASE2
NCT00012012	COMPLETED	Cervical Cancer; Radiation Toxicity	Radiation Therapy Oncology Group	2001-08	PHASE1; PHASE2
NCT00052884	TERMINATED	Drug/Agent Toxicity by Tissue/Organ; Multiple Myeloma and Plasma Cell Neoplasm	Eastern Cooperative Oncology Group	2004-01-22	PHASE1
NCT00003211	COMPLETED	Brain and Central Nervous System Tumors	St. Jude Children's Research Hospital	1996-10	PHASE2
NCT00006012	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Radiation Toxicity	Alliance for Clinical Trials in Oncology	2001-02	PHASE1; PHASE2
NCT00003193	COMPLETED	Head and Neck Cancer; Oral Complications	Massachusetts General Hospital	1998-01	PHASE1; PHASE2
NCT00006105	COMPLETED	Bladder Cancer; Drug/Agent Toxicity by Tissue/Organ	University of Chicago	2000-06	PHASE2
NCT00003811	COMPLETED	Childhood Germ Cell Tumor; Drug/Agent Toxicity by Tissue/Organ; Extragonadal Germ Cell Tumor; Ovarian Cancer	Children's Oncology Group	2000-04	PHASE2
NCT00086099	Completed	Leukemia\|Acute Myeloid Leukemia	MedImmune LLC	2004-07	Phase 1\|Phase 2
NCT00003407	WITHDRAWN	Drug/Agent Toxicity by Tissue/Organ; Leukemia; Myelodysplastic Syndromes; Neutropenia	Rush University Medical Center	2001-02-13	PHASE2
NCT00003624	TERMINATED	Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Neurotoxicity; Ovarian Cancer; Primary Peritoneal Cavity Cancer; Sarcoma	Gynecologic Oncology Group	1998-12	PHASE2
NCT00130143	Completed	Head and Neck Cancer\|Lung Cancer	The Dale & Frances Hughes Cancer Center\|MedImmune LLC	2003-06	Not Applicable
NCT00002643	COMPLETED	Neutropenia; Sarcoma	National Cancer Institute (NCI)	1995-04	PHASE2
NCT00136474	Completed	Lymphoma\|Hodgkin''s Disease\|Non-Hodgkin''s Lymphoma	Dana-Farber Cancer Institute\|Brigham and Women''s Hospital\|Beth Israel Deaconess Medical Center\|MedImmune LLC	2003-05	Phase 2
NCT00003127	COMPLETED	Endometrial Cancer	SWOG Cancer Research Network	1998-02	PHASE2
NCT00004919	COMPLETED	Unspecified Childhood Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	1999-12	PHASE1
NCT00004166	COMPLETED	Ovarian Cancer; Quality of Life	Northwestern University	1999-10	PHASE3
NCT00025298	TERMINATED	Drug/Agent Toxicity by Tissue/Organ; Head and Neck Cancer; Oral Complications; Radiation Toxicity	European Organisation for Research and Treatment of Cancer - EORTC	2001-07	PHASE2
NCT00003926	TERMINATED	Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Chordoma; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Retinoblastoma; Sarcoma	Masonic Cancer Center, University of Minnesota	1998-11	PHASE1
NCT00003425	COMPLETED	Breast Cancer; Leukemia; Lymphoma; Neuroblastoma; Ovarian Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific	University of Kentucky	1997-12	PHASE1; PHASE2
NCT00003313	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Oral Complications; Radiation Toxicity	Radiation Therapy Oncology Group	1998-09	PHASE3
NCT00005598	COMPLETED	Myelodysplastic Syndromes	University of Michigan Rogel Cancer Center	2000-10	PHASE2
NCT00003307	COMPLETED	Prostate Cancer; Radiation Toxicity	University of Arizona	1998-03	PHASE2
NCT00003777	TERMINATED	Head and Neck Cancer	Abramson Cancer Center at Penn Medicine	1998-12	PHASE2
NCT00003144	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific	NYU Langone Health	1997-08	PHASE1
NCT00003048	COMPLETED	Myelodysplastic Syndromes	M.D. Anderson Cancer Center	1997-06-05	PHASE2
NCT00004176	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Radiation Toxicity	Washington University School of Medicine	1998-10	PHASE2
NCT00003269	COMPLETED	Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Lymphoma; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Scripps Health	1998-02	PHASE2
NCT00003136	COMPLETED	Ovarian Cancer; Primary Peritoneal Cavity Cancer	University of Chicago	1996-12	PHASE1; PHASE2
NCT00003225	COMPLETED	Colorectal Cancer	Jonsson Comprehensive Cancer Center	1997-07	PHASE1; PHASE2
NCT00003405	WITHDRAWN	Leukemia	Rush University Medical Center	1998-04	PHASE2
NCT00003294	COMPLETED	Leukemia; Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific	Roswell Park Cancer Institute	1997-05	PHASE1
NCT00003072	COMPLETED	Lung Cancer; Neurotoxicity; Ovarian Cancer	University of California, San Francisco	1997-05	PHASE2
NCT00003582	COMPLETED	Carcinoma of Unknown Primary; Head and Neck Cancer	University of Miami	1988-05	PHASE1; PHASE2
NCT00003580	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Head and Neck Cancer; Oral Complications; Radiation Toxicity	University of Tennessee	1998-06	PHASE2
NCT00003415	COMPLETED	Leukemia; Myelodysplastic Syndromes	University of Arizona	1998-09	PHASE1; PHASE2
NCT00003123	UNKNOWN	Myelodysplastic Syndromes	Providence Hospital	1997-08	PHASE2
NCT00003089	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Lung Cancer	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	1997-07	PHASE2
NCT00004264	UNKNOWN	Drug/Agent Toxicity by Tissue/Organ; Lung Cancer	University of Wisconsin, Madison	1997-07	PHASE1; PHASE2
NCT00003681	UNKNOWN	Anemia; Myelodysplastic Syndromes	European Organisation for Research and Treatment of Cancer - EORTC	1998-08	PHASE2
NCT00003583	UNKNOWN	Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Radiation Toxicity	University of Florida	1997-06	PHASE2
NCT00003268	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Leukemia	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	1998-01	PHASE1
NCT00003068	COMPLETED	Breast Cancer; Drug/Agent Toxicity by Tissue/Organ	University of Arizona	1997-06	PHASE2
NCT00003827	UNKNOWN	Leukemia; Myelodysplastic Syndromes	ALZA	1999-01	PHASE2
NCT00004036	UNKNOWN	Chronic Myeloproliferative Disorders; Drug/Agent Toxicity by Tissue/Organ; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific	The Cleveland Clinic	1997-11	PHASE1
NCT00003251	UNKNOWN	Drug/Agent Toxicity by Tissue/Organ; Head and Neck Cancer; Radiation Toxicity	University of Illinois at Chicago	1997-12	PHASE1; PHASE2
NCT00003252	COMPLETED	Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific	Rush North Shore Medical Center	1997-12	PHASE4
NCT00003555	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	State University of New York - Upstate Medical University	1998-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2023-07-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amifostine trihydrate is an organic thiophosphate prodrug that is selectively dephosphorylated by membrane-bound alkaline phosphatase in normal tissues into its active free thiol metabolite, WR-1065, which scavenges toxic reactive oxygen species and donates hydrogen atoms to repair damaged cellular DNA. By preferentially accumulating in non-neoplastic tissues with higher alkaline phosphatase activity and microvascular perfusion, this action reduces treatment-limiting adverse effects including radiation toxicity, xerostomia, mucositis, and drug-induced neurotoxicity in patients receiving chemoradiotherapy for head and neck cancer, leukemia, and gynecologic malignancies.

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>).