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

Sponsor

TG Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02164006

Collaborator

(none)

Enrollment

Locations

Arm

22.7

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 11, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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 Names: brentuximab vedotin: Adcetris

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 Names:

brentuximab vedotin: Adcetris

Outcome Measures

Primary Outcome Measures

Maximum Tolerated Dose acceptable for participants [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

Overall Response Rate [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

Duration of Response [Up to 1 year]
To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	TG Therapeutics Investigational Trial Site	Duarte	California	United States	91010
2	TG Therapeutics Investigational Trial Site	San Diego	California	United States	92093
3	TG Therapeutics Investigational Trial Site	Sarasota	Florida	United States	34232
4	TG Therapeutics Investigational Trial Site	Detroit	Michigan	United States	48201