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 May 2014 by TG Therapeutics, Inc.
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01767766
First received: January 9, 2013
Last updated: May 8, 2014
Last verified: May 2014
  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: 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 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01767766

Contacts
Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

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

No publications provided

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01767766     History of Changes
Other Study ID Numbers: TGR-1202-101 (HEMREF 31)
Study First Received: January 9, 2013
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014