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

• Sponsor: TG Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01767766
• Collaborator: SCRI Development Innovations, LLC (Other)
• Enrollment: 90
• Locations: 7
• Arm: 1
• Actual Duration (Months): 60.8
• Patients Per Site: 12.9
• Patients Per Site Per Month: 0.2

Study Details

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.

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

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Jan 7, 2013
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Overall Response Rate [Up to 1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	TG Therapeutics Trial Site	Sarasota	Florida	United States	34232
2	TG Therapeutics Trial Site	Hackensack	New Jersey	United States	07601
3	TG Therapeutics Trial Site	New York	New York	United States	10019
4	TG Therapeutics Trial Site	Durham	North Carolina	United States	27710
5	TG Therapeutics Trial Site	Cincinnati	Ohio	United States	45242
6	TG Therapeutics Trial Site	Nashville	Tennessee	United States	37203
7	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TG Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01767766
• Other Study ID Numbers: TGR-1202-101 (HEMREF 31)
• First Posted: Jan 14, 2013
• Last Update Posted: Aug 23, 2021
• Last Verified: Aug 1, 2021

• Additional relevant MeSH terms: Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, T-Cell, Peripheral; Hematologic Neoplasms

Study Results

No Results Posted as of Aug 23, 2021