A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy
This study is currently recruiting participants.
Verified March 2013 by AEterna Zentaris
Sponsor:
AEterna Zentaris
Collaborators:
University of Miami
Miami VA Healthcare System
University of Miami Sylvester Comprehensive Cancer Center
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01234519
First received: November 2, 2010
Last updated: March 22, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.
| Condition | Intervention | Phase |
|---|---|---|
|
Urothelial Carcinoma |
Drug: AEZS-108 Drug: AEZS-108 at MTD |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by AEterna Zentaris:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) [ Time Frame: Day 1 of each 21-day cycle ] [ Designated as safety issue: Yes ]Toxicity per Common Terminology Criteria for Adverse Events (CTCAE)
Secondary Outcome Measures:
- Objective tumor response [ Time Frame: Within 5 days of cycle 4, then every 3 cycles ] [ Designated as safety issue: No ]Response evaluation criteria in solid tumors (RECIST) criteria
- Progression-free survival [ Time Frame: last cycle ] [ Designated as safety issue: No ]
- Pharmacokinetics [ Time Frame: cycle 1 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: last cycle ] [ Designated as safety issue: No ]
- Circulating tumor cell levels [ Time Frame: last cycle ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase 1
Maximum tolerated dose (MTD) determination in 4 sequential cohorts of patients (3-6 patients/cohort)
|
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
Other Names:
|
|
Experimental: Phase II
AEZS-108 at MTD to determine efficacy in 40 patients
|
Drug: AEZS-108 at MTD
2-hour IV infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles
Other Names:
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234519
Contacts
| Contact: Judes Fleurimont | 305-243-5601 |
Locations
| United States, Florida | |
| University of Miami Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Principal Investigator: Gustavo Fernandez, MD | |
| United States, Pennsylvania | |
| Univerity of Pennsylvania | Recruiting |
| Philadelphie, Pennsylvania, United States, 19104 | |
| Contact: Karen McGibney, RN 215-662-6388 | |
| Principal Investigator: David Vaughn, MD | |
Sponsors and Collaborators
AEterna Zentaris
University of Miami
Miami VA Healthcare System
University of Miami Sylvester Comprehensive Cancer Center
Investigators
| Principal Investigator: | Gustavo Fernandez, MD | University of Miami |
More Information
No publications provided
| Responsible Party: | AEterna Zentaris |
| ClinicalTrials.gov Identifier: | NCT01234519 History of Changes |
| Other Study ID Numbers: | AEZS-108-046, EProst # 20091095 |
| Study First Received: | November 2, 2010 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AEterna Zentaris:
|
ureter cancer renal pelvis cancer bladder cancer urethra |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013