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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Peripheral T-Cell Lymphoma; Hodgkin's Lymphoma	Drug: TGR-1202	Phase 1

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	January 2013
Actual Primary Completion Date :	March 2018
Estimated Study Completion Date :	September 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: TGR-1202; TGR-1202 Daily Oral Dose	Drug: TGR-1202; TGR-1202 Daily Oral Dose

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Maximum Tolerated Dose acceptable for participants [ Time Frame: 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 :

1. Overall Response Rate [ Time Frame: Up to 1 year ]
   To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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;

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
TG Therapeutics Trial Site
Sarasota, Florida, United States, 34232
United States, New Jersey
TG Therapeutics Trial Site
Hackensack, New Jersey, United States, 07601
United States, New York
TG Therapeutics Trial Site
New York, New York, United States, 10019
United States, North Carolina
TG Therapeutics Trial Site
Durham, North Carolina, United States, 27710
United States, Ohio
TG Therapeutics Trial Site
Cincinnati, Ohio, United States, 45242
United States, Tennessee
TG Therapeutics Trial Site
Nashville, Tennessee, United States, 37203
United States, Wisconsin
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

TG Therapeutics, Inc.

SCRI Development Innovations, LLC

Investigators

Study Chair:	Howard Burris, MD, FACP	SCRI Development Innovations, LLC

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 PI3Kδ and casein kinase-1ε 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.

Responsible Party:	TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01767766 History of Changes
Other Study ID Numbers:	TGR-1202-101 (HEMREF 31)
First Posted:	January 14, 2013
Last Update Posted:	March 20, 2018
Last Verified:	March 2018

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Neoplasms by Histologic Type	Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia; Leukemia, B-Cell