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A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma

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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