Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by TG Therapeutics, Inc.
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
TG Therapeutics, Inc. Identifier:
First received: January 9, 2013
Last updated: February 24, 2015
Last verified: February 2015

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

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Peripheral T-Cell Lymphoma
Hodgkin's Lymphoma
Drug: TGR-1202
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

Resource links provided by NLM:

Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose acceptable for participants [ Time Frame: 28 days (1 cycle of therapy) ] [ Designated as safety issue: Yes ]
    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TGR-1202
TGR-1202 Daily Oral Dose
Drug: TGR-1202
TGR-1202 Daily Oral Dose


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01767766

Contact: TG Therapeutics Clinical Support Team 212-554-4484

United States, Alabama
TG Therapeutics Trial Site Recruiting
Birmingham, Alabama, United States, 35213
Contact    615-329-7247   
United States, Florida
TG Therapeutics Trial Site Recruiting
Sarasota, Florida, United States, 34232
Contact    615-329-7247   
United States, New Jersey
TG Therapeutics Trial Site Recruiting
Hackensack, New Jersey, United States, 07601
Contact    615-329-7247   
United States, New York
TG Therapeutics Trial Site Recruiting
New York, New York, United States, 10019
Contact    615-329-7247   
United States, North Carolina
TG Therapeutics Trial Site Recruiting
Durham, North Carolina, United States, 27710
Contact    615-329-7247   
United States, Tennessee
TG Therapeutics Trial Site Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-329-7247   
United States, Wisconsin
TG Therapeutics Investigational Trial Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact    615-329-7247   
Sponsors and Collaborators
TG Therapeutics, Inc.
SCRI Development Innovations, LLC
Study Chair: Howard Burris, MD, FACP SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: TG Therapeutics, Inc. Identifier: NCT01767766     History of Changes
Other Study ID Numbers: TGR-1202-101 (HEMREF 31)
Study First Received: January 9, 2013
Last Updated: February 24, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoma, T-Cell
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on February 27, 2015