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A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy

Phase 1/Phase 2
18 Years
Not Enrolling
Acute Myeloid Leukemia

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Trial Information

A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy

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 administered in two different schedules in patients with AML. The
PXD101 plus idarubicin treatment will be repeated at suitable intervals (target is every 3
weeks for schedule A and every 2 weeks for schedule B) depending upon toxicities or disease
progression. Safety and efficacy assessments will be performed at every cycle.

Schedule A uses PXD101 by 30 min infusion daily for 5 days every 3 weeks with escalating
doses of idarubicin.

Schedule B uses escalating doses of continuous infusion (48h) of PXD101 alone or in
combination with idarubicin.

In both regimens the trial may be expanded at the Maximum Tolerated Dose (MTD).

Inclusion Criteria:


1. Signed consent

2. AML patients:

1. above 60 years in first relapse or refractory.

2. 18-60 years 2nd relapse or refractory to at least two intensive chemotherapy

3. 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.

3. Performance status (ECOG) ≤ 2

4. Age ≥ 18 years

5. Acceptable liver, renal and bone marrow function as defined

6. Serum potassium within normal range.

7. Acceptable coagulation status as defined

8. Precautions for female patients with reproductive potential as defined

Exclusion Criteria:

1. Treatment with investigational agents within the last 4 weeks

2. Prior treatment with HDAC (Histone deacetylases) inhibitors including valproic acid

3. Prior anti-leukemic therapy (except hydroxyurea) within the last 3 weeks of trial

4. Co-existing active infection (including HIV) or any co-existing medical condition
likely to interfere with trial procedures, including significant cardiovascular

5. Altered mental status precluding understanding of the informed consent process and/or
completion of the necessary study procedures.

6. Concurrent second malignancy.

7. History of hypersensitivity to idarubicin

8. Cumulative idarubicin dose exceeding 100 mg/m², or a (with respect cardiotoxicity)
corresponding dose of other anthracyclines

9. LVEF (left ventricular ejection fraction) below normal range (< 45% )

10. Known Central Nervous System (CNS) leukemia

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety and tolerance (Maximum Tolerated Dose, Dose Limiting Toxicity) and efficacy (Response rate (CR or PR))

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Hervé Dombret, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital St. Louis, Paris, France


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

May 2009

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • PXD101
  • Belinostat
  • Idarubicin
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid