A Phase 1/2 interventional study of AEZS-108 and AEZS-108 at MTD in Urothelial Carcinoma, sponsored by AEterna Zentaris. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-15.
Sponsored by AEterna Zentaris · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.
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 toxicity.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →AEterna Zentaris is the lead sponsor of 34 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort). Patients will be enrolled in cohorts of 3 at a specified AEZS-108 dose beginning with 160mg/m\^2. Enrollment will be suspended until all members of a cohort have been observed for dose limiting toxicities (DLT) for a period of 3 weeks (1 cycle of AEZS-108) from initial treatment with AEZS-108. Dose escalation will proceed within each cohort according to a specific scheme where DLT is defined.
Drug: AEZS-108
Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort).
Drug: AEZS-108 at MTD
Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort).
Drug: AEZS-108
Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort).
Drug: AEZS-108
AEZS-108 at MTD to determine efficacy in up to 40 patients.
Drug: AEZS-108
128, 160, 210 or 267 mg/m2, 2-hour intravenous (IV) infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles
Also known as: ZEN-008, AN-152, D-81858
2-hour IV infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles
Also known as: ZEN-008, AN-152, D-81858
Maximum tolerated dose (MTD)
Toxicity per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Day 1 of each 21-day cycle
Objective tumor response
Response evaluation criteria in solid tumors (RECIST) criteria.
Time frame: Within 5 days of cycle 4, then every 3 cycles
Progression-free survival (PFS)
Time elapsed from the start of treatment to the date of documented progression or death, whichever comes first.
Time frame: last cycle
Pharmacokinetics (PK)
To evaluate PK parameters of a single dose AEZS-108 and explore whether the PK parameters are associated with cardiac effects as measured by electrocardiography.
Time frame: cycle 1
Overall survival
Time elapsed from the start of treatment until death.
Time frame: last cycle
Circulating tumor cell (CTC) levels
To quantify tumor cells and attempt to correlate their presence and response to the outcomes of this study.
Time frame: last cycle
This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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AEterna Zentaris