Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01180426
• Other study ID #: CHR-2797-045
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 5, 2010
• Last updated: February 14, 2012
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: February 2012
• Source: Chroma Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CHR-2797
120mg once daily oral for 48 weeks

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	MD Anderson	Houston	Texas
United States	UCLA Division of Hematology/Oncology	Los Angeles	California
United States	New York Presbyterian Hospitacl	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Chroma Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of extended treatment with tosedostat	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	Protocol mandated visits every 12 weeks	Yes
Secondary	Efficacy of extended treatment with tosedostat	The secondary outcome will be assessed using the following parameters: Overall survival; Relapse-free survival; Event-free survival; Clinical responses (Complete Remission, Complete Remission with Incomplete Platelet Recovery, Morphological Leukemia-Free State, Partial Remission, Stable Disease, Progressive Disease) including best response and time to response; Duration of clinical responses.	Protocol-mandated visits every 12 weeks	No