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Clinical Trials/EUCTR2009-010548-32-SE
EUCTR2009-010548-32-SE
Active, not recruiting
Phase 1

A phase Ib/IIb, open-label, multi-center study of oral Panobinostat (LBH589) administered with 5-Azacitidine (Vidaza®) in adult patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) - N/A

ovartis Pharma Services AG0 sites119 target enrollmentStarted: December 19, 2011Last updated:
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ConditionsMyelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML)MedDRA version: 19.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10009018 Term: Chronic myelomonocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsVidaza

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
119
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •Adult patients (age \= 18 years) who are candidates for treatment with 5\-Aza and present with one of the following:
  • •intermediate\-2 or high\-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS). OR
  • •AML with multilineage dysplasia and maximum of 30% blasts (former RAEB\-T according to FAB) OR
  • •chronic myelomonocytic leukemia (CMML)
  • •ECOG performance status \= 2
  • •Patients must have the following laboratory values unless elevations are considered due to MDS or leukemia: AST/SGOT and/or ALT/SGPT \= 2\.5 x ULN; serum creatinine \= 1\.5 x ULN; serum bilirubin (total and direct) \= 2 x ULN; serum electrolytes (i.e, calcium, magnesium and potassium) within normal ranges for the institution.
  • •Negative pregnancy test
  • •Patients who are not clinically euthyroid
  • •Written informed consent obtained prior to any screening procedures
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •Planned hematopoietic stem\-cell transplantation (HSCT)
  • •Patients with therapy\-related MDS
  • •Patients with therapy\-related AML and/or relapsed/refractory AML
  • •Clinical symptoms suggesting CNS leukemia
  • •Concurrent therapy with any other investigational agent
  • •Prior treatment with deacetylase inhibitor(s)
  • •Prior treatment with 5\-Azacytidine or 5\-aza\-2'\-deoxycytidine
  • •Time windows for prior therapies: Last dose of therapy, including cytokines and/or retinoids, immunotherapy, low\-dose ara\-C, investigational agent less than 28 days with the exception of hydroxyurea (24 hours) prior to receipt of study medication or AEs that have not recovered at least to NCI CTCAE Grade 1\.
  • •Patients with impaired cardiac function including any of the following:
  • •Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmia, clinically significant resting bradycardia (\<50 beats per minute), QTcF \> 460 ms on screening ECG, or right bundle branch block \+ left anterior hemiblock (bifascicular block)

Investigators

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A phase Ib/IIb, open-label, multi-center study of oral Panobinostat (LBH589) administered with 5-Azacitidine (Vidaza®) in adult patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) - N/AMyelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML)MedDRA version: 14.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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A phase Ib/IIb, open-label, multi-center study of oral Panobinostat (LBH589) administered with 5-Azacitidine (Vidaza®) in adult patients with myelodysplastic syndromes (MDS), chronic myelomonocyticleukemia (CMML) or acute myeloid leukemia (AML) - N/AMyelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML)MedDRA version: 14.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2009-010548-32-DEovartis Pharma Services AG64