A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

May 31, 2018

Study Completion Date

October 31, 2022

Conditions
Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMantle Cell Lymphoma
Interventions
DRUG

TGR-1202

Capsules taken whole daily with water and with food

DRUG

Ibrutinib

Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges

Trial Locations (5)

93940

Pacific Cancer Care, Monterey

06105

St. Francis Hospital and Cancer Center, Hartford

04412

Eastern Maine Medical Center/ Northern Light Cancer Care, Brewer

02115

Dana Farber Cancer Institute, Boston

02215

Beth Israel Deaconness Medical Center, Boston

All Listed Sponsors
collaborator

TG Therapeutics, Inc.

INDUSTRY

collaborator

The Leukemia and Lymphoma Society

OTHER

collaborator

Blood Cancer Research Partnership

OTHER

lead

Dana-Farber Cancer Institute

OTHER

NCT02268851 - A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL | Biotech Hunter | Biotech Hunter