Clinical trial · Interventional
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
NCT01180426CI-TRIAL-00006272unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHR-2797 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tosedostat
- interventionNames
- Drug: CHR-2797
Primary outcomes (1)
- measure
- Safety and Tolerability of extended treatment with tosedostat
- timeFrame
- Protocol mandated visits every 12 weeks
- 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
Secondary outcomes (1)
- measure
- Efficacy of extended treatment with tosedostat
- timeFrame
- Protocol-mandated visits every 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.