EUCTR2009-013691-47-HU
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pharmacyclics LLC
- Enrollment
- 156
- 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 \= 2\.
- •\- Adequate haematological, renal, hepatic and cardiac 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
Similar Trials
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 LeukaemiaHodgkin'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 leukaemiaEUCTR2009-013691-47-FRInstitut de Recherches Internationales Servier
Active, not recruiting
Phase 1
Phase I/II dose-escalation study of S 78454 in LymphomaHodgkin'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]EUCTR2009-013691-47-GBPharmacyclics LLC135
Active, not recruiting
Phase 1
Phase I/II dose-escalation study of S 78454 in LymphomaEUCTR2009-013691-47-BEPharmacyclics. LLC156
Terminated
Phase 1
Phase I dose-escalation study of oral administration of S055746 in patients with Acute Myeloid Leukaemia or Myelodysplastic SyndromeISRCTN73586707Institut de Recherches Internationales Servier (France)80
Completed
Phase 1
Phase I study of oral administration of S 78454 in association with doxorubicin in patients with solid tumourSolid tumoursCancerMalignant neoplasm, unspecifiedISRCTN55052510Institut de Recherches Internationales Servier (France)36