Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

Phase 2

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: CHR-2797

• Registration Number: NCT01180426
• Lead Sponsor: Chroma Therapeutics

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-15
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tosedostat	CHR-2797	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of extended treatment with tosedostat	Protocol mandated visits every 12 weeks	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

Name	Time	Method
Efficacy of extended treatment with tosedostat	Protocol-mandated visits every 12 weeks	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.

Trial Locations

Locations (6)

UCLA Division of Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

MD Anderson; 🇺🇸 Houston, Texas, United States

John Theurer Cancer Center; 🇺🇸 Hackensack, New Jersey, United States

New York Presbyterian Hospitacl; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States