Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

Sponsor

Chroma Therapeutics (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01180426

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: CHR-2797	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tosedostat	Drug: CHR-2797 120mg once daily oral for 48 weeks

Arm

Intervention/Treatment

Experimental: Tosedostat

Drug: CHR-2797

120mg once daily oral for 48 weeks

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Division of Hematology/Oncology	Los Angeles	California	United States	90095
2	University of Michigan	Ann Arbor	Michigan	United States	48109-2800
3	John Theurer Cancer Center	Hackensack	New Jersey	United States	07601
4	New York Presbyterian Hospitacl	New York	New York	United States	10021
5	Duke University Medical Center	Durham	North Carolina	United States	27710
6	MD Anderson	Houston	Texas	United States	77030-4009