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The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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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 MichiganAnn Arbor, Michigan  48109-0624
Duke University Medical CenterDurham, North Carolina  27710
MD AndersonHouston, Texas  77230
John Theurer Cancer CenterHackensack, New Jersey  07601
UCLA Division of Hematology/OncologyLos Angeles, California  90095
New York Presbyterian HospitaclNew York, New York  10021