EUCTR2009-013691-47-FR
Active, not recruiting
Phase 1
Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia
ConditionsHodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)MedDRA version: 12.0Level: LLTClassification code 10020206Term: Hodgkin's diseaseMedDRA version: 12.0Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphomaMedDRA version: 12.0Level: LLTClassification code 10008993Term: Chronic lymphoid leukaemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)
- Sponsor
- Institut de Recherches Internationales Servier
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- HD or NHL that has relapsed or is refractory to conventional, standard form of therapy.
- •\- CLL that has relapsed or is refractory to conventional, standard form of therapy.
- •\- Ability to swallow oral capsule(s) without difficulty.
- •\- Estimated life expectancy \> 12 weeks.
- •\- ECOG performance status \= 1\.
- •\- Adequate haematological, renal and hepatic functions.
- •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
Exclusion Criteria
- •\- Allogeneic bone marrow transplant.
- •\- Major surgery within previous 4 weeks.
- •\- Concurrent therapeutic anticoagulation by AVK (Phase I part only).
- •\- Corticosteroids \> 20 mg prednisone equivalent per day.
- •\- Immunotherapy, chemotherapy (nitrosoureas within 6 weeks) or radiotherapy within previous 4 weeks.
- •\- Patients treated by valproic acid.
- •\- Any other previous (in the last 5 years) or concurrent cancer, other than resected non melanoma skin cancer or cancer in situ of the uterine cervix.
- •\- Risk factors for, or use of drugs known to prolong QTc interval or that may be associated with Torsades de Pointes.
Outcomes
Primary Outcomes
Not specified
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