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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
Columbia University Medical Center
New York, New York, United States
Overall Response Rate
The sum of patients with partial responses and complete responses.
Time frame: Up to 3 years
Progression Free Survival (PFS) After Treatment With TGR-1202
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Time frame: Up to 3 years
Duration of Response (DoR) After Treatment With TGR-1202
The time of initial response until documented tumor progression.
Time frame: Up to 3 years
Number of Dose Delays
The number of instances of patients having a dose of study drug delayed 1 or more days.
Time frame: Up to 3 years
Number of Dose Reductions
The number of instances of patients having to reduce the dosage of study drug based on specified toxicities.
Time frame: Up to 3 years
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] broken down by adverse event and CTCAE v4.0 grade of each event.
Time frame: Up to 3 years
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