Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients

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: NCT02164006
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: TGR-1202 + brentuximab vedotin Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: TGR-1202 + brentuximab vedotin
TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
 Drug: TGR-1202 + brentuximab vedotin
TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
Other Name: brentuximab vedotin: Adcetris


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Duration of Response [ Time Frame: Up to 1 year ]
    To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
TG Therapeutics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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
Keywords provided by TG Therapeutics, Inc.:
Hodgkin's
Additional relevant MeSH terms:
Layout table for MeSH terms
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