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Clinical Trials/NCT01613976
NCT01613976CompletedPhase 1

A Phase Ib, Open-label, Multi-center, Dose-escalation Study of Oral Panobinostat (LBH589) Administered With 5-Azacitidine (Vidaza®) in Adult Japanese Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML)

Novartis Pharmaceuticals1 site in 1 country10 target enrollmentStarted: August 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Incidence of Dose Limiting Toxicitiy(DLT)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to confirm the safety and tolerability of oral panobinostat (PAN) in combination with a fixed dose of 5-Azacitidine (5-Aza) in adult Japanese patients with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Japanese patients who are candidates for treatment with 5-Aza and present with one of the following:
  • •intermediate-2 or high-risk MDS 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 CMML
  • •Patient has an ECOG performance status of ≤ 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; electrolyte panel without clinically relevant abnormalities

Exclusion Criteria

  • •Patient who is planned for or has history of hematopoietic stem-cell transplantation (HSCT)
  • •Patients with relapsed/refractory AML
  • •Patient is receiving concurrent anti-cancer therapy
  • •Patient has received prior treatment with deacetylase inhibitors (DACi)
  • •Patient has received prior treatment with 5-Aza or 6-aza-2'-deoxycytidine (decitabine)
  • •Patient has shown suspected hypersensitivity to 5-Aza or Mannitol
  • •Patients with impaired cardiac function
  • •Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pontes if such treatment cannot be discontinued or switched to a different medication prior to starting study treatment
  • •Patients with clinical evidence of relevant mucosal or internal bleeding
  • •Patient has any other concurrent severe and/or uncontrolled medical conditions
  • •Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

Panobinostat and Azacitidine

Experimental

combination regimen

Intervention: Panobinostat (Drug)

Outcomes

Primary Outcomes

Incidence of Dose Limiting Toxicitiy(DLT)

Time Frame: first 5 weeks of treatment period

DLT will be assessed during PK run-in period (up to 7 days) and 1st cycle (28 days)

Secondary Outcomes

  • PK parameter - Cmax(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
  • PK parameter - Tmax(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
  • PK parameter - AUC (AUC0-48, AUC0-tlast)(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
  • PK parameter - T1/2 (apparent oral clearance, volume distribution)(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
  • PK parameter - AUC0-inf(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
  • Trough level of PAN in combination with 5-Aza(Day 4, 5, 8 of the 1st cycle; pre-dose (0 hour))
  • Frequency and severity of Adverse Events (AEs)(Participants will be followed for the duration of treatment, an expected average of 6 months)
  • Laboratory abnormalities(duration of treatment, an expected average of 6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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