A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy
Stopped early · Phase 1/Phase 2
Conditions studied: Urothelial Carcinoma
In brief
The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.
Key facts
- Study ID
- NCT01234519
- Run by
- AEterna Zentaris
- People needed
- 12
- Starts
- 2010-11-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2018-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Univerity of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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