Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Lymphoma, Non-Hodgkin

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Hodgkin Disease

Lymphoma, B-Cell

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Hodgkin Lymphoma

All Drugs and Chemicals

Abexinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart ("BID"), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).

Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I.

PCI-24781

Thorsten Graef, MD

The first part of the study will determine the highest dose of study drug that can be taken without causing serious side effects in patients with lymphoma. The appropriate dose determined from the first part of the study will be used in the second part of the study to assess disease response in 2 different types of lymphoma patients.

Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma

Phase I/II Dose-Escalation Study of the Pan-Histone Deacetylase (HDAC) Inhibitor PCI-24781 in Lymphoma

Number of patients experienced DLT in each cohort

Pharmacyclics LLC.

Cohort 1(30 mg/m2, 5days/wk)/Phase I

Cohort 2(45 mg/m2, 5days/wk)/Phase I

Cohort 3(45 mg/m2, 7days/wk)/Phase I

Cohort 4(60 mg/m2,7days/wk)/Phase I

Follicular/Phase II

Mantle Cell Lymphoma/Phase II

Cohort 1(30 mg/m2, 5days/wk)/Phase 1

Cohort 2(45 mg/m2, 5days/wk)/Phase 1

Cohort 3(45 mg/m2, 7days/wk)/Phase 1

Cohort 4(60 mg/m2,7days/wk)/Phase 1

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Thorsten Graef

Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I

Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I

Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I

Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I

Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response

Spots Global Cancer Trial Database for Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial