Clinical trial · Interventional
A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy
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
NCT01234519CI-TRIAL-00032093terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruitment
Summary
Brief summary (as posted)
The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEZS-108 | Drug | — | UNRESOLVED |
| AEZS-108 at MTD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase 1 - Cohort 1
- description
- 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.
- interventionNames
- Drug: AEZS-108
- type
- EXPERIMENTAL
- label
- Phase 1 - Cohort 2
- description
- Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort).
- interventionNames
- Drug: AEZS-108 at MTD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.