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

Primary Purpose

Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TGR-1202
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • TG Therapeutics Trial Site
  • TG Therapeutics Trial Site
  • TG Therapeutics Trial Site
  • TG Therapeutics Trial Site
  • TG Therapeutics Trial Site
  • TG Therapeutics Trial Site
  • TG Therapeutics Investigational Trial Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TGR-1202

Arm Description

TGR-1202 Daily Oral Dose

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose acceptable for participants
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

Secondary Outcome Measures

Overall Response Rate
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202

Full Information

First Posted
January 9, 2013
Last Updated
August 20, 2021
Sponsor
TG Therapeutics, Inc.
Collaborators
SCRI Development Innovations, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01767766
Brief Title
Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
Official Title
A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
Collaborators
SCRI Development Innovations, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma, Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TGR-1202
Arm Type
Experimental
Arm Description
TGR-1202 Daily Oral Dose
Intervention Type
Drug
Intervention Name(s)
TGR-1202
Intervention Description
TGR-1202 Daily Oral Dose
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose acceptable for participants
Description
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Time Frame
28 days (1 cycle of therapy)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Burris, MD, FACP
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
TG Therapeutics Trial Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
TG Therapeutics Trial Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
TG Therapeutics Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
TG Therapeutics Trial Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
TG Therapeutics Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
TG Therapeutics Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29475723
Citation
Burris HA 3rd, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20.
Results Reference
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Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

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