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Clinical Trials/EUCTR2008-002983-32-DE
EUCTR2008-002983-32-DEActive, not recruitingNot Applicable

A Phase II Study of Oral Single Agent Panobinostat in Patients with Refractory de novo or secondary Acute Myelogenous Leukemia (AML) - N/A

ovartis Pharma Services AG0 sites164 target enrollmentStarted: June 8, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
164
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Stratum A Specific Inclusion Criterion:
  • •Refractory AML with confirmed initial diagnosis of de novo AML (excluding
  • •Stratum B Specific Inclusion Criterion:
  • •Refractory AML with confirmed initial diagnosis of AML (excluding APL)
  • •secondary to precedent AHD or MDS with either condition being diagnosed
  • •at least three months before confirmed diagnosis of AML . [Patients may
  • •have received no prior treatment or treatment with conventional care
  • •regimens, including best supportive care , low dose cytarabine, intensive
  • •chemotherapy, hypomethylating agents (azacitidine, decitabine), or other
  • •therapies (e.g. lenalidomide)] for precedent MDS/AHD.
  • •Stratum A or B General Inclusion Criteria:
  • •1. Written informed consent prior to study-specific screening procedures.
  • •2. Age = 18 years old
  • •3. Patients with refractory AML (according to Estey 1996b)], whose
  • •is primary refractory (= no complete remission following initial
  • •induction therapy), OR
  • •has relapsed within 12 months after CR1 and for whom salvage (reinduction)
  • •chemotherapy is not indicated for documented clinical
  • •reasons OR documented patient refusal OR
  • •has relapsed within 12 months after CR1 and patient has failed
  • •one salvage (re-induction) (Failure or relapse after CR2)
  • •4. Eastern Cooperative Group (ECOG) performance status = 2
  • •5. Laboratory values defined as follows:
  • •Electrolyte panel WNL for the institution (potassium and magnesium
  • •values < lower limit of normal must be corrected to WNL prior to
  • •Total calcium (corrected for serum albumin) or ionized calcium WNL
  • •for the institution
  • •AST/SGOT and ALT/SGPT = 2.5 x ULN (NCI CTCAE Gr 1)
  • •Serum creatinine = 1.5 x ULN (NCI CTCAE Gr 1)
  • •Serum bilirubin = 1.5 x ULN (NCI CTCAE Gr 1) unless attributed to
  • •underlying disease
  • •INR = 1.5 and PTT WNL. Patients receiving anticoagulation therapy
  • •(e.g. coumadin, heparin) are eligible provided anticoagulation
  • •therapy can be discontinued or changed to parenteral medications
  • •while the platelet count is less than 50,000/mm3
  • •Negative serum pregnancy test (within 7 days of first dose)
  • •Negative urine pregnancy test immediately prior to first dose
  • •Clinically euthyroid (hypothyroidism corrected with supplementation
  • •is permitted)
  • •6. Patient has received a minimum of one and a maximum of three
  • •administrations of conventional remission induction therapy (this may
  • •include consolidation and/or HSCT) for newly diagnosed AML.
  • •7. Previous therapy for AML has stopped at least 2 weeks or at least five half lives, whichever is longer, before the first dose of study drug
  • •8. Patient has recovered from toxicity of previous AML treatment, including
  • •= Gr 1 non-hematologic toxicity prior to the first dose of study drug
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years)
  • +1 more not shown

Exclusion Criteria

  • •Stratum A or B General Exclusion Criteria:
  • •1. Patients with initial diagnosis of AML secondary to ionizing
  • •radiation/cytotoxic therapy (e.g. alkylating agents) for precedent
  • •2. Patients requiring valproic acid for any medical condition during the
  • •study or within 5 days prior to the first dose of study drug
  • •3. Clinical symptoms suggesting CNS leukemia (patients with neurologic
  • •symptoms must undergo lumbar puncture and a CT scan or MRI of the
  • •brain to exclude CNS involvement)
  • •4. Patients receiving supportive therapy related to complications of
  • •allogeneic transplantation, including infections or graft versus host
  • •(GVH) directed therapy
  • •5. Patients who have received either hydroxyurea or glucocorticosteroids
  • •for prevention of leukostasis less than 24 hours before the first dose of
  • •6. Patients with another malignancy (with the exception of prior MDS for
  • •secondary AML patients in Stratum B) unless disease-free for at least 3
  • •years following the completion of curative intent therapy. Patients with
  • •treated non-melanoma skin cancer, in situ carcinoma, or cervical
  • •intraepithelial neoplasm regardless of the disease-free duration, are
  • •eligible if definitive treatment for the condition has been completed
  • •7. 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 tachyarrhythmias, clinically significant resting bradycardia
  • •(<50 bpm), QTcF = 450 ms on screening ECG, or right bundle
  • •branch block + left anterior hemiblock (bifascicular block)
  • •LVEF < lower limit of institutional normal, as assessed by ECHO or
  • •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
  • •Angina pectoris or acute myocardial infarction (MI) within 6 months
  • •Other clinically significant heart disease (e.g. uncontrolled
  • •hypertension or history of poor compliance with a antihypertensive
  • •8. Other concurrent severe and/or uncontrolled medical conditions (e.g.,
  • •uncontrolled diabetes mellitus, chronic obstructive or chronic restrictive
  • •pulmonary disease including dyspnea at rest from any cause) or history
  • •of serious organ dysfunction or disease involving the heart, kidney or
  • •liver and/or known seropositive HIV (HIV screening testing is not
  • •9. Patient has an impairment of gastrointestinal (GI) function or GI disease
  • •that may significantly alter the absorption of oral panobinostat (e.g.,
  • •ulcerative disease, uncontrolled vomiting, grade > 1 diarrhea,
  • •malabsorption syndrome, obstruction, or stomach and/or small bowel
  • •10. Psychiatric disorder that interferes with ability to understand the study
  • •and give informed consent, and/or would impact study participation or
  • •11. Concurrent use of medications that have a relative risk of prolonging the
  • •QT interval or of inducing Torsade de Pointes, if such treatment cannot
  • •be discontinued or switched to a different medication prior to the first
  • •dose of study drug
  • •12. Female patients who are pregnant or breast-feeding or patients of
  • •childbearing potential (WOCBP) not willing to use a double barrier
  • •method of contraception during the study and for 3 months following the
  • +1 more not shown

Investigators

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