Status:
COMPLETED
A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this randomized, two-arm, open-label expansion phase study was to collect preliminary efficacy data of panobinostat at the recommended phase II dose (RPIID) level in combination with az...
Detailed Description
The primary objective of the phase lb portion of this study was to determine the maximum tolerated dose (MTD )and/or recommended phase ll dose (RPIID) of oral panobinostat in combination with a fixed ...
Eligibility Criteria
Inclusion
- Phase l:
- Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia who are eligible for Vidaza treatment
- ECOG performance status greater less than or equal to 2
- Phase ll:
- Adult patients (age ≥ 18 years) who were 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)
- Patients must have had 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; electrolyte panel within normal ranges (WNL) for the institution.
Exclusion
- Phase l:
- Prior treatment with deacetylase inhibitors
- Concurrent therapy with any other investigational agent
- Phase ll:
- Planned hematopoietic stem-cell transplantation (HSCT)
- Patients with therapy-related MDS
- Patients with therapy-related AML and/or relapsed/refractory AML
- 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)
- Presence of unstable atrial fibrillation (ventricular response rate \>100 bpm). Patients with stable atrial fibrillation are eligible provided they do not meet the other cardiac exclusion criteria
- Previous history of angina pectoris or acute MI within 6 months
- Screening LVEF \<45% by echocardiography or MUGA
- Other clinically significant heart disease (e.g. uncontrolled hypertension or history of poor compliance with an antihypertensive regimen).
- Any of concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example:
- Uncontrolled diabetes
- Active or uncontrolled infection
- Uncontrolled hypothyroidism
- Acute or chronic liver or renal disease
- Patient had evidence of clinically significant mucosal or internal bleeding
Key Trial Info
Start Date :
December 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2019
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00946647
Start Date
December 2 2009
End Date
April 29 2019
Last Update
August 4 2020
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgia Health Sciences University Dept. of MCG
Augusta, Georgia, United States, 30912
2
Goshen Center for Cancer Care IU Cancer Center
Indianapolis, Indiana, United States, 46202
3
University of Kansas Hospital and Medical Center SC - Univ KS
Kansas City, Kansas, United States, 66160
4
Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215