TGR1202 in Relapsed and Refractory Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT03178201|
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : July 26, 2019
The primary objective is to determine the overall response rate (ORR) of TGR-1202 in R/R FL.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: TGR-1202||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Phosphoinositide-3-Kinase-Delta Inhibitor TGR-1202 in Patients With Relapsed or Refractory Follicular Lymphoma|
|Actual Study Start Date :||August 20, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive 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.
Other Name: formerly as RP5307
- Overall Response Rate [ Time Frame: Up to 3 years ]The sum of patients with partial responses and complete responses.
- Progression Free Survival (PFS) after treatment with TGR-1202 [ Time Frame: Up to 3 years ]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.
- Duration of Response (DoR) after treatment with TGR-1202 [ Time Frame: Up to 3 years ]The time of initial response until documented tumor progression.
- Number of dose delays [ Time Frame: Up to 3 years ]The number of instances of patients having a dose of study drug delayed 1 or more days.
- Number of dose reductions [ Time Frame: Up to 3 years ]The number of instances of patients having to reduce the dosage of study drug based on specified toxicities.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 3 years ]Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] broken down by adverse event and CTCAE v4.0 grade of each event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178201
|Contact: Changchun Deng, MD, PhDemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10019|
|Contact: Changchun Deng, MD, PhD 212-326-5720 firstname.lastname@example.org|
|Principal Investigator: Changchun Deng, MD, PhD|
|Principal Investigator:||Changchun Deng, MD||Assistant Professor of Medicine|