Trials / Unknown
UnknownNCT01180426
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Chroma Therapeutics · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHR-2797 | 120mg once daily oral for 48 weeks |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2010-08-12
- Last updated
- 2012-02-15
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01180426. Inclusion in this directory is not an endorsement.