The scope of this study is the treatment of patient acute myeloid leukaemia. MedDRA version: 14.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: F14512
Product Code: F14512
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: F14512
Other d
Sponsors
Pierre Fabre Medicament
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy all the following inclusion criteria before they are allowed to participate in the study: - Cytogenetically and molecularly characterized AML according to WHO classification (excluding acute promyelocytic leukemia), - De novo or secondary AML arising from myelodysplastic syndrome or myeloproliferative syndrome or therapy-related (if the patient is cancer-free for at least 3 years excluding non-melanoma skin cancer) who meets the following criteria: oPhase I part: -Refractory AML after failure of one induction chemotherapy regimen or who had recurrence of disease =65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
Exclusion criteria: If any of the following apply, the patient must not enter the study: - Patient candidate for allograft at study entry, - Acute promyelocytic leukaemia, - Clinical symptoms suggesting active central nervous system leukaemia, - Peripheral blast count superior or equal to 30.000/mm3, - Severe complication of leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, - Current active infection; serious concurrent, uncontrolled medical disorder, - Thrombocytopenia refractory to platelet transfusion, - Prior total body irradiation up to more than 12 Gy, - Known HIV, HTLV1, Hepatitis B or C positivity, - History of another malignancy within the past 3 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix, - Active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmia not controlled by medication or uncontrolled congestive heart failure [New York Heart Association NYHA class III-IV], - Clinically relevant cardiovascular, hepatic, neurological or other systemic disease making implementation of the protocol difficult, - Concurrent treatment with any other anti-cancer treatment, - Participation in another trial of an investigational agent within 30 days before study entry, - Known hypersensitivity to the study drug or to drugs with similar chemical structures, - Concurrent treatment with inhibitors of ornithine decarboxylase or polyamine analogues, - Chronic treatment with systemic or inhaled steroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I part: To determine the maximal tolerated dose (MTD) of F14512 administered as a three-hour daily infusion given for 5 consecutive days in combination with cytarabine 1 g/m²/day for 5 consecutive days in patients 60 years old or older with refractory or relapsing AML. Phase II part: To evaluate the efficacy of F14512 in combination with cytarabine (rate of CR + CRi) in AML patients 60 years old and older in first relapse. ; Secondary Objective: Phase I part: - To determine the recommended dose (RD) of F14512 in combination with cytarabine to be used in the Phase II part, - To assess the safety of F14512, - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine, - To assess the pharmacokinetics of F14512 in combination with cytarabine. Phase II part: - To extend the evaluation of safety at the RD, - To assess Relapse-Free Survival, Progression-Free Survival, remission duration and Overall Survival, - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine, - To assess the pharmacokinetics of F14512 in combination with cytarabine at recommended dose. ; Primary end point(s): Phase I part: To determine the maximal tolerated dose (MTD) of F14512 administered as a three-hour daily infusion given for 5 consecutive days in combination with cytarabine 1 g/m²/day for 5 consecutive days in patients 60 years old or older with refractory or relapsing AML. Phase II part: To evaluate the efficacy of F14512 in combination with cytarabine (rate of CR + CRi) in AML patients 60 years old and older in first relapse. ; Timepoint(s) of evaluatio | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I part: - To determine the recommended dose (RD) of F14512 in combination with cytarabine to be used in the Phase II part, - To assess the safety of F14512, - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine, - To assess the pharmacokinetics of F14512 in combination with cytarabine Phase II part: - To extend the evaluation of safety at the RD, - To assess Relapse-Free Survival, Progression-Free Survival, remission duration and Overall Survival, - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine, - To assess the pharmacokinetics of F14512 in combination with cytarabine at recommended dose. ; Timepoint(s) of evaluation of this end point: Phase I part: Dose escalation of F14512 will be stopped once the MTD is reached. Phase II part: Up to a maximum of 6 cycles at investigator's discretion | — |
Countries
France, Italy, Spain
Contacts
Public ContactMaud brandely
Pierre Fabre Medicament
Outcome results
None listed