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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 July 2015 |
Main ID: |
EUCTR2008-002986-30-FR |
Date of registration:
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16/11/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A phase Ib, open-label, multi-center dose-finding study of oral panobinostat (LBH589) in combination with ara-C and mitoxantrone as salvage therapy for refractory or relapsed acute myeloid leukemia - N/A
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Scientific title:
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A phase Ib, open-label, multi-center dose-finding study of oral panobinostat (LBH589) in combination with ara-C and mitoxantrone as salvage therapy for refractory or relapsed acute myeloid leukemia - N/A |
Date of first enrolment:
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08/01/2010 |
Target sample size:
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26 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002986-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria Relapsed after receiving up to 1 prior induction regimens (first relapse) or patients who are refractory (no CR) to not more than one prior combination chemotherapy induction regimen. Age more than 18 years ECOG performance status = 2 Patients must have the following laboratory values unless considered due to leukemia: AST/SGOT and/or ALT/SGPT = 2.5 x ULN; Serum creatinine = 1.5 x ULN or GFR = 60 mL/min; Total and direct serum bilirubin = 1.5 x ULN; electrolyte panel within normal ranges for the institution unless attributed to the underlying disease. Eligible for ara-C and mitoxantrone chemotherapy Written informed consent obtained prior to any screening procedures 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Subjects with Acute Promyelocytic Leukemia (APL) Concurrent therapy with any other investigational agent Patients who received more than maximal two chemotherapy induction cycles and four chemotherapy consolidation cycles for their AML disease CNS involvement 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 last dose of study drug. Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment. Prior treatment with deacetylase inhibitors Patients who have received cumulative doses of = 360 mg/m2 of doxorubicin (or its equivalent to other anthracyclines, e.g. 225 mg/m2 of idarubicin, 900 mg/m2 of daunorubicin, 140 mg/m2 of mitoxantrone, 450 mg/m2 of pegylated liposomal doxorubicin hydrochloride). Any of concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example: Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmia, clinically significant resting bradycardia (<50 beats per minute), QTcF > 460 ms on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block) 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 Previous history of angina pectoris or acute MI within 6 months Baseline LVEF <45% by echocardiography Other clinically significant heart disease (e.g. uncontrolled hypertension or history of poor compliance with an antihypertensive regimen) Uncontrolled diabetes Active or uncontrolled infection Uncontrolled hypothyroidism Acute or chronic liver or renal disease Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat (e.g., ulcerative diseases, diarrhea, malabsorption syndrome, or small bowel resection) Time windows for prior therapies: All acute toxic effects of any prior therapy of leukemic disease must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade <2 (with exception of chemotherapy-induced alopecia) Last dose of prior chemotherapy, immunotherapy or investigational agent no less than 14 days prior to receipt of study medication and have recovered at least CTCAE Grade <2, except for hydroxyurea which must be finished 48 hours before first administration. Wide field radiotherapy = 4 weeks or limited radiation for palliation = 2 weeks prior to starting the study treatment or who have not recovered from side effects of such therapy Drugs which may cause QT prolongation and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. HIV, Hepatitis B/C infection according to the medical history (testing will not be performed) Unwilling or unable to comply with the protocol Inability to swallow capsules
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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refractory or relapsed acute myeloid leukemia MedDRA version: 9.1
Level: LLT
Classification code 10000886
Term: Acute myeloid leukemia
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Intervention(s)
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Product Name: panobinostat Product Code: LBH589 Pharmaceutical Form: Capsule, hard INN or Proposed INN: panobinostat CAS Number: 404950-80-7 Current Sponsor code: LBH589 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Product Name: panobinostat Product Code: LBH589 Pharmaceutical Form: Capsule, hard INN or Proposed INN: panobinostat CAS Number: 404950-80-7 Current Sponsor code: LBH589 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Trade Name: Alexan Product Name: cytarabine Pharmaceutical Form: Solution for infusion INN or Proposed INN: cytarabine CAS Number: 147-94-4 Other descriptive name: Ara C Concentration unit: gm/m2 gram(s)/square meter Concentration type: equal Concentration number: 0.5-
Trade Name: Mitoxantron NC Product Name: mitoxantrone Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: mitoxantrone CAS Number: 65271-80-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2-
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Primary Outcome(s)
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Secondary Objective: Dose escalation and expansion part: To assess the safety profile of panobinostat in combination with ara-C and mitoxantrone in this patient population during the escalation and expansion phase (at MTD) of the study.
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Primary end point(s): Dose escalation part: Incidence of DLT
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Main Objective: To determine the maximum-tolerated dose (MTD) in terms of the incidence of dose-limiting toxicity (DLT) of panobinostat in combination with ara-C and mitoxantrone at a fixed dose in adult patients with relapsed or is primary refractory acute myeloid leukemia (AML).
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Secondary ID(s)
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N/A
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CLBH589B2116
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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