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

NCT02268851 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-11-15

Study results available
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Summary

This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.

Conditions

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

Sponsors & Collaborators

  • TG Therapeutics, Inc.

    collaborator INDUSTRY

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Blood Cancer Research Partnership

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Matthew Davids, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-05-31
Completion
2022-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02268851 on ClinicalTrials.gov