Trials / Completed
CompletedNCT02323139
A Study of LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients
A Single-arm Dose Finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Groupe Francophone des Myelodysplasies · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine.
Detailed description
Dose escalation of LDE255 will be performed over time using a rolling 6 design to determine the safety of the combination with azacitidine. The starting dose will be 400 mg. Azacitidine will be continued at maximum tolerated dose (MTD). Evaluation will be based on cycle 1 toxicity profile. Once MTD will be determined, 20 additional patients will be treated at recommended dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azacitidine and LDE255 | Azacitidine at maximum tolerated dose. LDE255 at dose escalation (200, 400 or 800 mg) |
Timeline
- Start date
- 2015-02-10
- Primary completion
- 2018-01-01
- Completion
- 2018-08-01
- First posted
- 2014-12-23
- Last updated
- 2018-12-06
Locations
24 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02323139. Inclusion in this directory is not an endorsement.