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

TG Therapeutics

Status and phase: Completed; Phase 1

Conditions: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Peripheral T-Cell Lymphoma

Treatments: Drug: TGR-1202

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01767766

TGR-1202-101 (HEMREF 31)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

TGR-1202

Experimental group

Description:

TGR-1202 Daily Oral Dose

Treatment:

Drug: TGR-1202