MedPath

Irofulven

Generic Name
Irofulven
Drug Type
Small Molecule
Chemical Formula
C15H18O3
CAS Number
158440-71-2
Unique Ingredient Identifier
6B799IH05A
Background

A novel anti-cancer compound synthesized by scientists at the University of California, San Diego more than a decade ago from toxins of the poisonous jack-o-lantern mushroom, has been granted “fast track” status by the U.S. Food and Drug Administration (FDA) after demonstrating promise against one of the most deadly cancers.

MGI-114 (Irofulven) is currently being developed by MGI PHARMA, Inc., an emerging oncology-focused pharmaceutical company based in Minneapolis. Phase III clinical trials involving the drug have been underway since early 2001 at sites in the U.S. and Europe.

Indication

Investigated for use/treatment in brain cancer, breast cancer, endometrial cancer, liver cancer, lung cancer, ovarian cancer, pancreatic cancer, pediatric indications, prostate cancer, and sarcoma.

Irofulven in AR-targeted and Docetaxel-Pretreated mCRPC Patients With Drug Response Predictor (DRP®)

Phase 2
Completed
Conditions
Metastatic Castration-Resistant Prostate Cancer Patients
Interventions
Combination Product: Prednisolone 10 mg
First Posted Date
2018-08-22
Last Posted Date
2025-01-23
Lead Sponsor
Allarity Therapeutics
Target Recruit Count
15
Registration Number
NCT03643107
Locations
🇩🇰

Rigshospitalet, Dept. Of Oncology, Copenhagen, Denmark

Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Liver Cancer
Interventions
First Posted Date
2006-09-11
Last Posted Date
2021-12-08
Lead Sponsor
Eisai Inc.
Target Recruit Count
63
Registration Number
NCT00374660

Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer

Phase 2
Completed
Conditions
Thyroid Cancer
First Posted Date
2005-07-28
Last Posted Date
2021-06-16
Lead Sponsor
Eisai Inc.
Target Recruit Count
35
Registration Number
NCT00124527

Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-07-28
Last Posted Date
2016-01-18
Lead Sponsor
Eisai Inc.
Target Recruit Count
135
Registration Number
NCT00124566

Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Interventions
First Posted Date
2004-09-13
Last Posted Date
2016-07-20
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
36
Registration Number
NCT00003666
Locations
🇺🇸

University of California San Diego Cancer Center, La Jolla, California, United States

🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

and more 45 locations

Irofulven in Treating Patients With Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Interventions
First Posted Date
2004-09-13
Last Posted Date
2018-10-25
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
26
Registration Number
NCT00003441
Locations
🇺🇸

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
First Posted Date
2004-08-26
Last Posted Date
2013-06-21
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00003390
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer

Phase 2
Completed
Conditions
Cervical Cancer
First Posted Date
2004-08-09
Last Posted Date
2013-06-19
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00005070

Irofulven in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Phase 2
Withdrawn
Conditions
Colorectal Cancer
Interventions
First Posted Date
2004-08-04
Last Posted Date
2014-03-07
Lead Sponsor
University of Chicago
Registration Number
NCT00003786
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

🇺🇸

Michiana Hematology/Oncology P.C., South Bend, Indiana, United States

🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

and more 6 locations

Irofulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer

Phase 2
Completed
Conditions
Pancreatic Cancer
First Posted Date
2004-08-04
Last Posted Date
2012-08-09
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
3
Registration Number
NCT00003760
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

🇺🇸

Brooke Army Medical Center, Fort Sam Houston, Texas, United States

🇺🇸

San Antonio Cancer Institute, San Antonio, Texas, United States

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