The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
60 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
Extension protocol to the OPAL Study (CHR-2797-038).
Study mimics normal clinical practice; few procedures and visits are therefore mandated by
the protocol. Timing of bone marrow assessment is also left at the investigator's
discretion.
Inclusion Criteria:
- Signed, informed consent
- Completion of Visit 11 in the OPAL Study (Month 6 Visit)
- Investigator's opinion that the subject would benefit from continued therapy with
tosedostat.
Exclusion Criteria:
- Any co-existing medical condition that in the Investigator's opinion will
substantially increase the risk associated with the subject's participation in the
study
- Psychiatric disorders or altered mental status precluding understanding of the
informed consent process and/or completion of the necessary studies
- Administration of any (other) investigational agent within 14 days of entry into
TOPAZ.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and Tolerability of extended treatment with tosedostat
Outcome Description:
Primary outcome will be assessed using the following procedures/data: Physical exams Vital signs Electrocardiography Laboratory parameters (hematology, chemistry, urinalysis) Adverse events Serious adverse events
Outcome Time Frame:
Protocol mandated visits every 12 weeks
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
CHR-2797-045
NCT ID:
NCT01180426
Start Date:
June 2010
Completion Date:
June 2013
Related Keywords:
- Acute Myeloid Leukemia
- Relapse Refractory Acute Myeloid Leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| MD Anderson | Houston, Texas 77230 |
| John Theurer Cancer Center | Hackensack, New Jersey 07601 |
| UCLA Division of Hematology/Oncology | Los Angeles, California 90095 |
| New York Presbyterian Hospitacl | New York, New York 10021 |
