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A Phase 2 Study of PXD101 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or Patients Over 60 With Newly-Diagnosed Acute Myelogenous Leukemia

Phase 2
18 Years
Not Enrolling
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

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Trial Information

A Phase 2 Study of PXD101 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or Patients Over 60 With Newly-Diagnosed Acute Myelogenous Leukemia


I. Evaluate the response rate (complete response and partial response) in patients with
acute myeloid leukemia treated with PXD101.


I. Evaluate the overall survival of these patients. II. Evaluate the duration of response in
these patients. III. Evaluate the toxicity of this drug in these patients.


I. Evaluate molecular response to PXD101.


Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for
6-12 months in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are obtained before and after study treatment for laboratory

After completion of study treatment, patients are followed periodically for 1 year.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed acute myelogenous

- The diagnosis must be made by bone marrow aspirate and biopsy; patients must have
routine cytochemical evaluation along with immunophenotyping done by flow cytometry;
cytogenetic analysis must also be performed

- For patients age 18-59 years, at least one prior regimen of induction chemotherapy is
required; patients who have been treated with bone marrow or stem cell
transplantation are eligible; there is no prior therapy requirement for patients age
> 60

- Patients for whom potentially curative treatment is available must be offered
this treatment and decline

- Life expectancy of greater than 3 months

- ECOG performance status =< 2 (Karnofsky >= 60%)

- Serum total bilirubin =< 2.0 mg/dl

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- Creatinine clearance >= 60 mL/min OR creatinine < 1.5 times ULN

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the activity or pharmacokinetics of PXD101 will be
determined following review of their case by the principal investigator

- Efforts should be made to switch patients with gliomas or brain metastases who
are taking enzyme inducing anticonvulsant agents to other medications

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written informed consent document

- Patients taking hydroxyurea for the purpose of cytoreduction should discontinue this
medication at least 24 hours prior to the initiation of therapy with PXD101

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- Patients with known central nervous system (CNS) disease should be excluded from this
clinical trial because of their poor prognosis and because they often develop
progressive neurologic dysfunction that would confound the evaluation of neurologic
and other adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PXD101

- Patients may not have had prior treatment with another HDAC inhibitor within 1 week
of initiation of therapy with PXD101; patients receiving valproic acid should stop
this medication at least 1 week prior to therapy with PXD101

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness that could compromise compliance with study

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with PXD101

- HIV-positive patients are ineligible

- Patients with a marked baseline prolongation of QT/QTc interval (e.g. repeated
demonstration of a QTc interval 500 msec), Long QT Syndrome, or the required use of
concomitant medication on PXD101 infusion days that may cause Torsade de Pointes
(including disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol,
bepridil, amiodarone, arsenic trioxide, cisapride, lidoflazine, clarithromycin,
erythromycin, halofantrine, pentamidine, sparfloxacin, domperidone, droperidol,
chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, and methadone)

- Significant cardiovascular disease including unstable angina pectoris, uncontrolled
hypertension, congestive heart failure related to primary cardiac disease, a
condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart
disease, or a myocardial infarction within 6 months prior to trial entry

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate a

Outcome Description:

Logistic regression will be used to investigate the role on response status.

Outcome Time Frame:

Up to 1 year

Safety Issue:


Principal Investigator

Kenneth Foon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Recurrent Adult Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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