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TGR1202 in Relapsed and Refractory Follicular Lymphoma

NCT03178201 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-07-16

Study results available
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Summary

The primary objective is to determine the overall response rate (ORR) of TGR-1202 in R/R FL.

Secondary Objectives

* Determine the genetic and other novel biological markers that may be predictive of response or resistance to TGR-1202 in patients with relapsed or refractory FL.
* Describe the Progression Free Survival (PFS), Duration of Response (DoR) after treatment with TGR-1202.
* Describe the number of dose delays and dose reductions and other safety profile.

Conditions

Interventions

DRUG

TGR-1202

Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days.

Sponsors & Collaborators

Principal Investigators

  • Changchun Deng, MD · Assistant Professor of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-20
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03178201 on ClinicalTrials.gov