A Phase I/II Trial of AEZS-108 in Locally Advanced Unresectable or Metastatic Luteinizing Hormone-releasing Hormone(LHRH) Positive Urothelial Carcinoma Patients Who Failed Platinum Based Chemotherapy
AEZS-108 is an investigational drug, combining luteinizing hormone-releasing hormone (LHRH),
an hormone and doxorubicin (a drug approved to treat different types of cancer).
Some tumors, such as those found in the urinary system (also called urothelial carcinomas),
have LHRH hormone receptors to which the LHRH hormone part of AEZS-108 is attracted.
AEZS-108 is expected to work by accumulating mostly on the surface of cancer cells that have
LHRH hormone receptors and by delivering doxorubicin more directly into the cells to kill
them. This would allow the use doxorubicin at lower doses and thus would cause less
In the first part of the study, the appropriate dose of AEZS-108 will be determined based on
its side effects. The best dose will be the highest one without severe side effects.
In the second part of the study, this best dose of AEZS-108 will be given to determine its
efficacy to stop the tumor from progressing.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD)
Toxicity per Common Terminology Criteria for Adverse Events (CTCAE)
Day 1 of each 21-day cycle
Gustavo Fernandez, MD
University of Miami
United States: Food and Drug Administration
|University Of Miami Miller School Of Medicine||Miami, Florida 33010|
|Univerity of Pennsylvania||Philadelphie, Pennsylvania 19104|