ISRCTN73586707
Terminated
Phase 1
Phase I dose-escalation study of the orally administrered selective Bcl-2 inhibitor S055746 as monotherapy for the treatment of patients with Acute Myeloid Leukaemia (AML) or high or very high risk Myelodysplastic Syndrome (MDS)
Institut de Recherches Internationales Servier (France)0 sites80 target enrollmentSeptember 4, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut de Recherches Internationales Servier (France)
- Enrollment
- 80
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 13/01/2017:
- •1\. Women or men aged \>\= 18 years
- •2\. Patients with cytologically confirmed and documented de novo, secondary or therapy¬related AML excluding acute promyelocytic leukaemia :
- •2\.1\. With relapsed or refractory disease without established alternative therapy or
- •2\.2\. \> or \= 65 years not previously treated for AML, who are not candidates for intensive chemotherapy or not candidates for standard chemotherapy
- •3\. Patients with cytollogically confirmed and documented MDS or non\-proliferative Chronic Myelomonocytic Leukaemia (CMML) patients, in relapse or refractory after previous treatment line including at least one hypomethylating agent (5\-azacytidine or decitabine):
- •3\.1\. With high or very high risk MDS and without established alternative therapy
- •3\.2\. Transformed to AML and without established alternative therapy
- •4\. Ability to swallow oral tablet(s)
- •5\. WHO performance status 0\-2
Exclusion Criteria
- •Current exclusion criteria as of 14/03/2018:
- •1\. Foreseeable poor compliance to the study procedures
- •2\. Legally incapacitated person under guardianship or trusteeship
- •3\. Pregnant or breastfeeding women
- •4\. Participation in therapeutic interventional study involving investigational drug intake at the same time or within 2 weeks or at least 5 half\-lives or patient already enrolled
- •5\. Previous treatment with a BH3 mimetic
- •6\. Patients who have not recovered to baseline or CTCAE\< or \= Grade 1 from toxicity due to all prior therapies received for the studied disease
- •7\. Any previous anti¬leukaemic treatment (AML, high or very high risk MDS) within at least 5 half\-lives or 2 weeks prior to the study entry except for hydroxyurea
- •8\. Any radiotherapy within 4 weeks before first intake
- •9\. Major surgery within 3 weeks before first intake of S 055746
Outcomes
Primary Outcomes
Not specified
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