Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
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ClinicalTrials.gov Identifier: NCT02164006 |
Recruitment Status :
Completed
First Posted : June 16, 2014
Last Update Posted : October 2, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hodgkin's Lymphoma | Drug: TGR-1202 + brentuximab vedotin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Brentuximab Vedotin in Combination With TGR-1202, a Novel PI3K Delta Inhibitor, in Patients With Hodgkins Lymphoma |
Actual Study Start Date : | June 11, 2014 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: TGR-1202 + brentuximab vedotin
TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
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Drug: TGR-1202 + brentuximab vedotin
TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
Other Name: brentuximab vedotin: Adcetris |
- Maximum Tolerated Dose acceptable for participants [ Time Frame: 21 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) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma
- Duration of Response [ Time Frame: Up to 1 year ]To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin

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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:
- Confirmed diagnosis of Hodgkin's Lymphoma
- Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria:
- Any major surgery, chemotherapy or immunotherapy within the last 21 days
- Known hepatitis B virus, hepatitis C virus or HIV infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Patients who had prior Allogeneic hematologic stem cell transplant are excluded

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): NCT02164006
United States, California | |
TG Therapeutics Investigational Trial Site | |
Duarte, California, United States, 91010 | |
TG Therapeutics Investigational Trial Site | |
San Diego, California, United States, 92093 | |
United States, Florida | |
TG Therapeutics Investigational Trial Site | |
Sarasota, Florida, United States, 34232 | |
United States, Michigan | |
TG Therapeutics Investigational Trial Site | |
Detroit, Michigan, United States, 48201 |
Responsible Party: | TG Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02164006 |
Other Study ID Numbers: |
TGR-BV-107 |
First Posted: | June 16, 2014 Key Record Dates |
Last Update Posted: | October 2, 2019 |
Last Verified: | October 2019 |
Hodgkin's |
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Brentuximab Vedotin Antibodies, Monoclonal Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |