A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

November 15, 2016

Study Completion Date

August 18, 2017

Conditions
Diffuse Large B-cell LymphomaFollicular LymphomaBurkitt Lymphoma
Interventions
DRUG

Alisertib

Dose escalation of alisertib: level 1 - 20 mg, level 2 - 30 mg, level 3 - 40 mg PO BID on Days 1-5 of six 21-day cycles, combined with R-EPOCH Rituximab, IV infusion on day 1 of each cycle; Etoposide, IV infusion for 96 hours on days 1, 2, 3, and 4 Doxorubicin, IV infusion for 96 hours on days 1, 2, 3, and 4 Vincristine, IV infusion for 96 hours on days 1, 2, 3, and 4 Cyclophosphamide, IV infusion for 15 minutes on day 5 Prednisone, PO daily on days 1, 2, 3, 4, and 5

Trial Locations (2)

27599

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hills

91010

City of Hope Comprehensive Cancer Center, Duarte

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER