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

January 9, 2013
May 8, 2014
January 2013
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01767766 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Peripheral T-Cell Lymphoma
  • Hodgkin's Lymphoma
Drug: TGR-1202
TGR-1202 Daily Oral Dose
Experimental: TGR-1202
TGR-1202 Daily Oral Dose
Intervention: Drug: TGR-1202
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
October 2014
August 2014   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com
United States
 
NCT01767766
TGR-1202-101 (HEMREF 31)
Yes
TG Therapeutics, Inc.
TG Therapeutics, Inc.
SCRI Development Innovations, LLC
Study Chair: Howard Burris, MD, FACP SCRI Development Innovations, LLC
TG Therapeutics, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP