Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180426

Enrollment

Registered

2010-08-12

Start date

2010-06-30

Completion date

2013-06-30

Last updated

2012-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Relapse Refractory Acute Myeloid Leukemia

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.

Interventions

DRUGCHR-2797

120mg once daily oral for 48 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026