Status:
COMPLETED
Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy
Lead Sponsor:
Valerio Therapeutics
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not suitable for standard i...
Detailed Description
This trial is an open-label, multi-centre, dose-escalation Phase I/II study to evaluate safety, explore efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with idarubicin ad...
Eligibility Criteria
Inclusion
- (abbreviated)
- Signed consent
- AML patients:
- above 60 years in first relapse or refractory.
- 18-60 years 2nd relapse or refractory to at least two intensive chemotherapy regimens.
- above 60 years with high risk features (cytogenetics, secondary or treatment related AML) d) above 60 years with myelodysplastic syndrome with \>10% blasts in bone marrow (WHO RAEB-2 (Refractory anemia with excess blasts-2)). For patients below 60 years potential curative treatments should have been exhausted.
- Performance status (ECOG) ≤ 2
- Age ≥ 18 years
- Acceptable liver, renal and bone marrow function as defined
- Serum potassium within normal range.
- Acceptable coagulation status as defined
- Precautions for female patients with reproductive potential as defined
Exclusion
- Treatment with investigational agents within the last 4 weeks
- Prior treatment with HDAC (Histone deacetylases) inhibitors including valproic acid
- Prior anti-leukemic therapy (except hydroxyurea) within the last 3 weeks of trial dosing
- Co-existing active infection (including HIV) or any co-existing medical condition likely to interfere with trial procedures, including significant cardiovascular disease
- Altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures.
- Concurrent second malignancy.
- History of hypersensitivity to idarubicin
- Cumulative idarubicin dose exceeding 100 mg/m², or a (with respect cardiotoxicity) corresponding dose of other anthracyclines
- LVEF (left ventricular ejection fraction) below normal range (\< 45% )
- Known Central Nervous System (CNS) leukemia
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00878722
Start Date
August 1 2007
End Date
April 1 2012
Last Update
July 28 2015
Active Locations (6)
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1
CHU Lapeyronie
Montpellier, France, 34295
2
Hôpital St. Louis
Paris, France, 75475
3
Uniklinik Homburg
Homburg, Germany, 66424
4
Uni Hospital Marburg
Marburg, Germany, 35043