Phase I/II dose-escalation study of S 78454 in Lymphoma
- Conditions
- Hodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)MedDRA version: 19.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10020206Term: Hodgkin's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10008993Term: Chronic lymphoid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-013691-47-BE
- Lead Sponsor
- Pharmacyclics. LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 156
- 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase I part:<br>- To assess the MTDs and the dose-limiting toxicities (DLTs) for each dosing schedule tested.<br>- To determine the optimal dosing schedule and its associated recommended Phase II dose.<br><br>Phase II part:<br>- To assess the objective response rate at the recommended dose of the optimal dosing schedule defined in the phase I part.;Secondary Objective: Phase I part:<br>- To determine the PK and PD profiles.<br>- To measure tumour response.<br><br>Phase II part:<br>- To assess the safety and tolerability.<br>- To assess the activity profile of S78454.<br>- To determine the PK and PD profiles.;Primary end point(s): - Phase I part : DLTs and MTDs.<br>- Phase II part: Objective response rate (ORR).;Timepoint(s) of evaluation of this end point: - DLTs and MTDs: at each visit.<br>- ORR : overall
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Safety<br>- PK parameters<br>- Acetylation state (histones) of proteins<br><br><br> ;Timepoint(s) of evaluation of this end point: - Safety : at each visit<br>- PK parameters: during the cycle 1<br>- Acetylation state (histones) of proteins: during the cycle 1