Spots Global Cancer Trial Database for A Study of LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients
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Trial Identification
Brief Title: A Study of LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients
Official Title: 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
Study ID: NCT02323139
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU d'Amiens, Amiens, , France
CHU d'Angers, Angers, , France
CH Henri Duffaut, Avignon, , France
CH de la C么te Basque, Bayonne, , France
H么pital Avicenne, Bobigny, , France
H么pital Henri Mondor, Cr茅teil, , France
CHU de Grenoble, Grenoble, , France
CH Le Mans, Le Mans, , France
IPC-Unit茅 d'H茅matologie 3, Marseille, , France
Centre Hospitalier de Meaux, Meaux, , France
CHU de Montpellier, Montpellier, , France
H么pital H么tel Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
H么pital Archet 1, Nice, , France
CHU de N卯mes, N卯mes, , France
H么pital Saint Louis - Service H茅matologie S茅nior, Paris, , France
H么pital Saint-Louis - Service d'h茅matologie AJA, Paris, , France
H么pital Cochin, Paris, , France
CHU de Haut-L茅v猫que, Pessac, , France
CH Lyon Sud, Pierre-B茅nite, , France
CH Annecy Genevois, Pringy, , France
H么pital Henri Becquerel, Rouen, , France
IUC Oncopole - M茅decine interne, Toulouse, , France
CHU Nancy-Brabois, Vand艙uvre-l猫s-Nancy, , France
Contact Details
Name: Thomas PREBET, MD
Affiliation: Paoli Calmettes institute
Role: PRINCIPAL_INVESTIGATOR
Name: Pierre FENAUX, MD, PHD
Affiliation: Saint-Louis Hospital, Paris, France
Role: STUDY_DIRECTOR
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