NCT03178201

TGR1202 in Relapsed and Refractory Follicular Lymphoma

Study of the Phosphoinositide-3-Kinase-Delta Inhibitor TGR-1202 in Patients With Relapsed or Refractory Follicular Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open label, phase II study of TGR-1202 in patients with relapsed or refractory (R/R) Grade 1, 2, or 3A follicular lymphoma (FL). FL is the most common subtype of indolent lymphoma. The prognosis of FL depends on the histologic grade, stage, treatment and age of the patient. More recently, efforts have been made to find novel regimens for the treatment of relapsed FL that do not contain non-specific cytotoxic agents. One of the important goals of this phase II study is to discover novel genetic, biochemical, and immunological markers that are associated with the response and safety of TGR-1202 in patients with FL. TGR-1202 blocks PI3K, a signal that is required for cancer to grow.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-20
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2017-06-06
• Last updated: 2021-07-16
• Results posted: 2021-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study