Status:
TERMINATED
A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy
Lead Sponsor:
AEterna Zentaris
Collaborating Sponsors:
University of Miami
Miami VA Healthcare System
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.
Detailed Description
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 thos...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma
- Expression of LHRH receptors confirmed by immunohistochemistry on archival cancer tissue
- Measurable disease on radiological studies
- Patients with Locally advanced unresectable or metastatic urothelial carcinoma
- Documented progression on at least one prior chemotherapy regimen which must have incorporated platinum based therapy
- Left ventricular ejection fraction (EF) \> 50%
- Eastern cooperative oncology group (ECOG) status of 0, 1 or 2
- Adequate bone marrow, renal and hepatic function
Exclusion
- Prior treatment with or allergy to any components of AEZS-108
- Active second malignancies other than non-melanoma skin cancers
- Ongoing use of an LHRH agonist (or antagonist)
- Presence of an active infection or fever \> 38.5 C, parenchymal brain metastases or uncontrolled intercurrent illness
- Prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone
- Patients who received radiotherapy within 4 weeks of entry
- Major surgery within the last 4 weeks and minor surgery in last 7 days
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01234519
Start Date
November 1 2010
End Date
November 1 2014
Last Update
March 15 2018
Active Locations (2)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
2
Univerity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104