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

Phase 1

Completed

• Conditions: Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Hodgkin's Lymphoma; Peripheral T-Cell Lymphoma
• Interventions: Drug: TGR-1202

• Registration Number: NCT01767766
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-07
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TGR-1202	TGR-1202	TGR-1202 Daily Oral Dose

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose acceptable for participants	28 days (1 cycle of therapy)	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 1 year	To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202

Trial Locations

Locations (2)

TG Therapeutics Trial Site; 🇺🇸 Nashville, Tennessee, United States

TG Therapeutics Investigational Trial Site; 🇺🇸 Milwaukee, Wisconsin, United States