amifostine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ETHYOL | — | 1996-03-15 – 1999-06-24 | fda.gov ↗ |
| Approved | US (FDA) | ETHYOL | — | 1995-12-08 | fda.gov ↗ |
Trials 62 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT01998529 Background | Aug 2014 → Aug 2020 | lung cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00571298 Background | Nov 2007 → Nov 2011 | malignant pleural mesothelioma | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00217542 Background | Jul 2005 → Jul 2008 | melanoma, renal cell carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00052884 Background | Jan 2004 → Sep 2007 | plasma cell neoplasm, poisoning | Eastern Cooperative Oncology Group | Terminated | No outcome recorded |
| Phase 1 | NCT00003927 Background | May 1999 → Mar 2023 | breast cancer | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00003555 Background | Jul 1998 → May 2003 | cancer of unknown primary site | State University of New York - Upstate Medical University | Completed | No outcome recorded |
| Phase 1 | NCT00003294 Background | May 1997 → Apr 1999 | leukemia, lymphoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT00318890 Background | Oct 2002 → Apr 2007 | malignant tumor of neck | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 1/2 | NCT00006012 Background | Feb 2001 → May 2006 | lung cancer, poisoning, radiation-induced disorder | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 1/2 | NCT00003425 Background | Dec 1997 → Jul 2002 | breast cancer, cancer of unknown primary site, leukemia, lymphoma +3 | University of Kentucky | Completed | No outcome recorded |
| Phase 1/2 | NCT00004264 Background | Jul 1997 → ? | lung carcinoma, poisoning | University of Wisconsin, Madison | Unknown | No outcome recorded |
| Phase 1/2 | NCT00003136 Background | Dec 1996 → Dec 2000 | ovarian cancer, primary peritoneal carcinoma | University of Chicago | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT00095927 Comparator | May 2003 → Jun 2007 | chemotherapy-induced toxicity, head and neck cancer, mucositis, radiation-induced disorder | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00136474 Comparator | May 2003 → May 2005 | Hodgkins lymphoma, non-Hodgkin lymphoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00006105 Background | Jun 2000 → Nov 2004 | chemotherapy-induced toxicity, urinary bladder cancer | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT00003211 Background | Oct 1996 → Jun 2007 | central nervous system neoplasm | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00217438 Background | Jul 2005 → Oct 2012 | plasma cell myeloma | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 83 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amifostine | “Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer.” NCT00158691 ↗77“Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia” NCT00086099 ↗ “Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT” NCT00167908 ↗ “RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine.” NCT02587442 ↗ |
| Known as | amifostine trihydrate | “amifostine (amifostine trihydrate) in reducing the toxicity associated with platinum agents” NCT00003994 ↗9“Drug: amifostine trihydrate” NCT00003425 ↗ “Drug: amifostine trihydrate” NCT00006012 ↗ “Drug: amifostine trihydrate” NCT00003926 ↗ “Drug: amifostine trihydrate” NCT00003927 ↗ “Drug: Amifostine trihydrate” NCT00040365 ↗ “Drug: amifostine trihydrate” NCT00004919 ↗ “Drug: amifostine trihydrate” NCT00003127 ↗ “Drug: amifostine trihydrate” NCT00003313 ↗ |
| Known as | Ethyol | “OBJECTIVES: Radiation Therapy Oncology Group (RTOG) 0116 was designed to test the ability of amifostine (Ethyol; MedImmune LLC, Gaithersburg, MD), a cytoprotective agent, to...” PMID 21892091 ↗ Oct 201111“Radiation Therapy Oncology Group (RTOG) trial 98-01, a phase III study testing the ability of a radioprotector (Amifostine [Ethyol, WR-2721]) to reduce the toxicity of an...” PMID 11917283 ↗ Jan 2002 “Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on...” NCT05167370 ↗ “Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer” NCT00081315 ↗ “A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation” NCT00003143 ↗ “Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia” NCT00086099 ↗ “Determination of the cytoprotective agent WR-2721 (Amifostine, Ethyol) and its metabolites in human blood” PMID 9771955 ↗ 1998 “A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer” NCT00601198 ↗ “Amifostine (WR 2721, Ethyol)” NCT00003582 ↗ “Ethyol (Amifostine)” NCT00130143 ↗ “Amifostine (Ethyol)” NCT00003415 ↗ “Ethyol (drug)” NCT00167908 ↗ |
| Known as | WR-2721 | “Radiation Therapy Oncology Group (RTOG) trial 98-01, a phase III study testing the ability of a radioprotector (Amifostine [Ethyol, WR-2721]) to reduce the toxicity of an...” PMID 11917283 ↗ Jan 20023“The purpose of this study was to determine whether amifostine (WR-2721) prevents or ameliorates clinically significant (grade 2 to 4) neurotoxicity associated with cisplatin...” PMID 14615449 ↗ Nov 2003 “Determination of the cytoprotective agent WR-2721 (Amifostine, Ethyol) and its metabolites in human blood” PMID 9771955 ↗ 1998 “Amifostine (WR 2721, Ethyol)” NCT00003582 ↗ |
| Route | Intravenous | “Amifostine IV over 15 minutes” NCT00002643 ↗ |