EUCTR2009-013691-47-GB
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: 18.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10020206 Term: Hodgkin's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10008993 Term: Chronic lymphoid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)
- Sponsor
- Pharmacyclics LLC
- Enrollment
- 135
- Status
- Active, not recruiting
- Last Updated
- 7 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 \= 2\.
- •\- 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 71
Exclusion Criteria
- •\- Allogeneic bone marrow transplant.
- •\- Major surgery within previous 4 weeks.
- •\- Concurrent therapeutic anticoagulation by AVK.
- •\- Patient previously treated by another HDAC Inhibitor than valproic acid (Phase II part).
- •\- Corticosteroids \> 20 mg prednisone equivalent per day within previous 10 days.
- •\- Immunotherapy, chemotherapy (nitrosoureas within 6 weeks) or radiotherapy within previous 4 weeks.
- •\- Patients treated by valproic acid within previous 5 days.
- •\- Any other previous (in the last 3 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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