Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
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
1 other identifier
interventional
16
1 country
4
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2014
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 2, 2019
October 1, 2019
1.9 years
June 12, 2014
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose acceptable for participants
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
21 days (1 cycle of therapy)
Secondary Outcomes (1)
Overall Response Rate
Up to 1 year
Other Outcomes (1)
Duration of Response
Up to 1 year
Study Arms (1)
TGR-1202 + brentuximab vedotin
EXPERIMENTALTGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
Interventions
TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
TG Therapeutics Investigational Trial Site
Duarte, California, 91010, United States
TG Therapeutics Investigational Trial Site
San Diego, California, 92093, United States
TG Therapeutics Investigational Trial Site
Sarasota, Florida, 34232, United States
TG Therapeutics Investigational Trial Site
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 16, 2014
Study Start
June 11, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
October 2, 2019
Record last verified: 2019-10