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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:
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 12, 2017
Last verified: May 2017
January 9, 2013
May 12, 2017
January 2013
September 2017   (Final data collection date for primary outcome measure)
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.
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 ]
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
Intervention Model: Single Group Assignment
Masking: No masking
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.
 
Active, not recruiting
90
October 2017
September 2017   (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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01767766
TGR-1202-101 (HEMREF 31)
Yes
Not Provided
Not Provided
Not Provided
TG Therapeutics, Inc.
TG Therapeutics, Inc.
SCRI Development Innovations, LLC
Study Chair: Howard Burris, MD, FACP SCRI Development Innovations, LLC
TG Therapeutics, Inc.
May 2017

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