Phase I/II dose-escalation study of S 78454 in Lymphoma

Phase 1

• Conditions: Hodgkin'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]

• Registration Number: EUCTR2009-013691-47-GB
• Lead Sponsor: Pharmacyclics LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-10
• Study Completion: 2017-02-10
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 135

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified