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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767766
First Posted: January 14, 2013
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
TG Therapeutics, Inc.
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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) ]
    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 ]
    To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202


Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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): NCT01767766


Locations
United States, Florida
TG Therapeutics Trial Site
Sarasota, Florida, United States, 34232
United States, New Jersey
TG Therapeutics Trial Site
Hackensack, New Jersey, United States, 07601
United States, New York
TG Therapeutics Trial Site
New York, New York, United States, 10019
United States, North Carolina
TG Therapeutics Trial Site
Durham, North Carolina, United States, 27710
United States, Ohio
TG Therapeutics Trial Site
Cincinnati, Ohio, United States, 45242
United States, Tennessee
TG Therapeutics Trial Site
Nashville, Tennessee, United States, 37203
United States, Wisconsin
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
TG Therapeutics, Inc.
SCRI Development Innovations, LLC
Investigators
Study Chair: Howard Burris, MD, FACP SCRI Development Innovations, LLC
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01767766     History of Changes
Other Study ID Numbers: TGR-1202-101 (HEMREF 31)
First Submitted: January 9, 2013
First Posted: January 14, 2013
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Leukemia, B-Cell