Trial Outcomes & Findings for Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma (NCT NCT02867618)

NCT ID: NCT02867618

Last Updated: 2021-07-16

Results Overview

The highest dose of the study treatment that does not cause unacceptable side effects.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2021-07-16

Participant Flow

3 out of 14 subjects were enrolled (consented) but not accrued into study and did not receive study treatment.

Participant milestones

Measure	Carfilzomib + TGR-1202 Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202 TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma

Baseline characteristics by cohort

Measure	Carfilzomib + TGR-1202 n=14 Participants Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202 TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib
Age, Customized 18-21 years	0 participants n=5 Participants
Age, Customized 22-29 years	1 participants n=5 Participants
Age, Customized 30-39 years	1 participants n=5 Participants
Age, Customized 40-49 years	0 participants n=5 Participants
Age, Customized 50-59 years	1 participants n=5 Participants
Age, Customized 60-69 years	2 participants n=5 Participants
Age, Customized 70-79 years	9 participants n=5 Participants
Age, Customized 80-89 years	0 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: PI left the institution, study data was not complete or analyzed for Carfilzomib (Phase 2).

The highest dose of the study treatment that does not cause unacceptable side effects.

Outcome measures

Measure

Carfilzomib + TGR-1202 n=11 Participants Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202 TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib

Maximum Tolerated Dose (MTD) (Phase 1) - TGR-1202 Only

800 mg

PRIMARY outcome

Timeframe: 9 months

Population: The data was not collected or analyzed due to PI leaving the institution.

Defined as best response (complete response and partial response) by 4 cycles.

Outcome measures

Outcome data not reported

Adverse Events

Carfilzomib + TGR-1202

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure

Carfilzomib + TGR-1202 n=11 participants at risk Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202 TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib

Blood and lymphatic system disorders Neutropenia

9.1% 1/11 • Number of events 1 • Up to 1 year post study treatment

Other adverse events

Adverse event data not reported

Additional Information

Ana Ignat

Columbia University

Phone: 212-305-3612

Email: ai2111@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place