Trial Information
A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
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;
- Primary central nervous system lymphoma or known intracranial involvement.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose acceptable for participants
Outcome Description:
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Outcome Time Frame:
28 days (1 cycle of therapy)
Safety Issue:
Yes
Principal Investigator
Michael R. Savona, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
TGR-1202-101 (HEMREF 31)
NCT ID:
NCT01767766
Start Date:
January 2013
Completion Date:
June 2014
Related Keywords:
- Non-Hodgkin's Lymphoma
- Chronic Lymphocytic Leukemia
- Peripheral T-cell Lymphoma
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Hematologic Neoplasms
Name | Location |
TG Therapeutics Trial Site |
Sarasota, Florida 34232 |
TG Therapeutics Trial Site |
Hackensack, New Jersey 07601 |
TG Therapeutics Trial Site |
Nashville, Tennessee 37203 |