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Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CHR-2797
Sponsored by
Chroma Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Relapse Refractory Acute Myeloid Leukemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Division of Hematology/Oncology
  • University of Michigan
  • John Theurer Cancer Center
  • New York Presbyterian Hospitacl
  • Duke University Medical Center
  • MD Anderson

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tosedostat

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 5, 2010
Last Updated
February 14, 2012
Sponsor
Chroma Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01180426
Brief Title
Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chroma Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Relapse Refractory Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tosedostat
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CHR-2797
Intervention Description
120mg once daily oral for 48 weeks
Primary Outcome Measure Information:
Title
Safety and Tolerability of extended treatment with tosedostat
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
Time Frame
Protocol mandated visits every 12 weeks
Secondary Outcome Measure Information:
Title
Efficacy of extended treatment with tosedostat
Description
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.
Time Frame
Protocol-mandated visits every 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UCLA Division of Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2800
Country
United States
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York Presbyterian Hospitacl
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

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