Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

August 20, 2021 updated by: TG Therapeutics, Inc.

A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34232
        • TG Therapeutics Trial Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • TG Therapeutics Trial Site
    • New York
      • New York, New York, United States, 10019
        • TG Therapeutics Trial Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • TG Therapeutics Trial Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • TG Therapeutics Trial Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TG Therapeutics Trial Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Refractory to or relapsed after at least 1 prior treatment regimen;
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
  • At least 18 years of age.

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks);
  • Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months;
  • Known hepatitis B virus, hepatitis C virus or HIV infection;
  • Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TGR-1202
TGR-1202 Daily Oral Dose
Drug: TGR-1202
TGR-1202 Daily Oral Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose acceptable for participants
Time Frame: 28 days (1 cycle of therapy)
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
28 days (1 cycle of therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 1 year
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Collaborators

SCRI Development Innovations, LLC

Investigators

  • Study Chair: Howard Burris, MD, FACP, SCRI Development Innovations, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2013

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (ESTIMATE)

January 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGR-1202-101 (HEMREF 31)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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