Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
This study is ongoing, but not recruiting participants.
Sponsor:
TG Therapeutics, Inc.
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01767766
First received: January 9, 2013
Last updated: February 1, 2016
Last verified: February 2016
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Purpose
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Peripheral T-Cell Lymphoma Hodgkin's Lymphoma |
Drug: TGR-1202 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Peripheral T-cell Lymphoma
U.S. FDA Resources
Further study details as provided by TG Therapeutics, Inc.:
Primary Outcome Measures:
- Maximum Tolerated Dose acceptable for participants [ Time Frame: 28 days (1 cycle of therapy) ] [ Designated as safety issue: Yes ]To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Secondary Outcome Measures:
- Overall Response Rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TGR-1202
TGR-1202 Daily Oral Dose
|
Drug: TGR-1202
TGR-1202 Daily Oral Dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767766
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767766
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
| Responsible Party: | TG Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01767766 History of Changes |
| Other Study ID Numbers: | TGR-1202-101 (HEMREF 31) |
| Study First Received: | January 9, 2013 |
| Last Updated: | February 1, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 29, 2016