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

This study is currently recruiting participants.
Verified March 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: March 9, 2014
Last verified: March 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
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   
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: March 9, 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 April 15, 2014