Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Peripheral T-cell Lymphoma
Interventions
DRUG

Belinostat

"Belinostat will be administered by intravenous infusion once daily for up to 5 days depending on the dose cohort as follows:~* Cohort 1: belinostat 1000 mg/m2 IV on Day 1~* Cohort 2: belinostat 1000 mg/m2 IV on Day 1-2~* Cohort 3: belinostat 1000 mg/m2 IV on Day 1-3~* Cohort 4: belinostat 1000 mg/m2 IV on Day 1-4~* Cohort 5: belinostat 1000 mg/m2 IV on Day 1-5"

DRUG

CHOP

"Cyclophosphamide - 750 mg/m2 - IV - Day 1~Vincristine - 1.4 mg/m2 - IV - Day 1~Doxorubicin - 50mg/m2 - IV - Day 1~Prednisone 100mg PO - On Day 1 Prednisone will be administered after chemotherapy part of CHOP, and on Day 2-5 after belinostat."

Trial Locations (8)

10019

Columbia University Medical Center/Center for Lymphiod Malignancies, New York

27705

Duke University Medical Center, Durham

30607

Northeast Georgia Cancer Care, LLC, Athens

55905

Mayo Clinic, Rochester

63110

Washington University School of Medicine, St Louis

06511

Yale University, New Haven

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

07962

Hematology - Oncology Associates of Northern NJ P.A, Morristown

Sponsors
All Listed Sponsors
lead

Acrotech Biopharma Inc.

INDUSTRY

NCT01839097 - Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL) | Biotech Hunter | Biotech Hunter