EUCTR2014-002752-50-FR
Active, not recruiting
Phase 1
Phase II clinical trial evaluating the efficacy of the dual inhibition of PIK/Akt/mTor signaling pathway by PF-05212384 (PKI-587) for patients with myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) or de novo relapsed or refractory AML - LAM-PIK
ConditionsMyeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) /or relapsed or refractory de novo AML /or de novo AML at diagnostic considered unfit to benefit from induction therapy with chemotherapy associated aplasiaMedDRA version: 17.1Level: LLTClassification code 10066572Term: AML progressionSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) /or relapsed or refractory de novo AML /or de novo AML at diagnostic considered unfit to benefit from induction therapy with chemotherapy associated aplasia
- Sponsor
- INSTITUT CURIE
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients belong to one of three categories:
- •1\.1\. Myeloid neoplasm secondary to chemo\-radiotherapy (t\-AML/MDS) aged 60 and over with unfavorable cytogenetics (ELN definition 2010\), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
- •1\.2\. Relapsed or refractory de novo AML aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
- •1\.3\. de novo AML at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
- •2\. Adequate glycemic balance defined by glycated hemoglobin (HbA1c) \= 8%
- •3\. Females of childbearing potential (FCBP) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
- •4\. ECOG/performance status \= 2
- •5\. Absence of severe or active infection
- •6\. Adequate systolic cardiac function (LVEF \= 50%)
- •7\. Adequate hepatic function: AST and ALT \= 3 times the upper limit of normal (ULN), bilirubin \= 1\.5 x ULN
Exclusion Criteria
- •1\. Glucose intolerance or diabetes mellitus, treated or untreated
- •2\. First cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
- •3\. AML secondary to MDS or myeloproliferative syndrome (WHO 2008 definitions)
- •4\. Acute promyelocytic leukaemia (APL or AML FAB3\) de novo or secondary to treatment (t\-APL)
- •5\. de novo or secondary CBF/AML
- •6\. de novo or secondary Ph1 positive AML defined by the presence of a t(9\.22\) or a BCR\-ABL transcript
- •7\. Leukocytes above 30\.000/mm3 (30 G/L) at enrollment
- •8\. Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
- •9\. Central nervous system leukemic involvement
- •10\. Pregnant or lactating women, or women of childbearing potential without effective contraception
Outcomes
Primary Outcomes
Not specified
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