CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
TGR-1202 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02268851
NCT02268851Phase 1Completed
CompareCT.gov

A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of the Novel PI3k Delta Inhibitor TGR-1202 in Combination With Ibrutinib in Patients With Select B-Cell Malignancies

Dana-Farber Cancer Institute·interventional·Posted Oct 20, 2014·Updated Nov 15, 2024

In Brief

A Phase 1 clinical trial evaluating TGR-1202 and Ibrutinib for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Mantle Cell Lymphoma. Completed, enrolled 45 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Mantle Cell Lymphoma
CountriesUnited States
CollaboratorsTG Therapeutics, Inc., The Leukemia and Lymphoma Society, Blood Cancer Research Partnership

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2014
Enrollment StartNov 1, 2014
Primary CompletionMay 1, 2018
Study CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.7 years ago

Interventions

TGR-1202drug

Capsules taken whole daily with water and with food

Ibrutinibdrug

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