Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01767766 |
Recruitment Status :
Completed
First Posted : January 14, 2013
Last Update Posted : August 23, 2021
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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 Type : | Interventional (Clinical Trial) |
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 : | January 7, 2013 |
Actual Primary Completion Date : | February 2018 |
Actual Study Completion Date : | February 2018 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767766
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 |
Study Chair: | Howard Burris, MD, FACP | SCRI Development Innovations, LLC |
Responsible Party: | TG Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01767766 |
Other Study ID Numbers: |
TGR-1202-101 (HEMREF 31) |
First Posted: | January 14, 2013 Key Record Dates |
Last Update Posted: | August 23, 2021 |
Last Verified: | August 2021 |
Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell, Peripheral Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia Leukemia, B-Cell Lymphoma, T-Cell Neoplasms by Site Hematologic Diseases |