Trial Outcomes & Findings for TGR1202 in Relapsed and Refractory Follicular Lymphoma (NCT NCT03178201)
NCT ID: NCT03178201
Last Updated: 2021-07-16
Results Overview
The sum of patients with partial responses and complete responses.
TERMINATED
PHASE2
5 participants
Up to 3 years
2021-07-16
Participant Flow
Participant milestones
| Measure |
TGR-1202
Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.
TGR-1202: Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
TGR-1202
Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.
TGR-1202: Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days.
|
|---|---|
|
Overall Study
Off study
|
5
|
Baseline Characteristics
TGR1202 in Relapsed and Refractory Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
TGR-1202
n=5 Participants
Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.
TGR-1202: Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: The data was not collected or analyzed due to the study was terminated prematurely due to slow to accrual and PI left the institution.
The sum of patients with partial responses and complete responses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The data was not collected or analyzed due to the study was terminated prematurely due to slow to accrual and PI left the institution.
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The data was not collected or analyzed due to the study was terminated prematurely due to slow to accrual and PI left the institution.
The time of initial response until documented tumor progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The data was not collected or analyzed due to the study was terminated prematurely due to slow to accrual and PI left the institution.
The number of instances of patients having a dose of study drug delayed 1 or more days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The data was not collected or analyzed due to the study was terminated prematurely due to slow to accrual and PI left the institution.
The number of instances of patients having to reduce the dosage of study drug based on specified toxicities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The data was not collected or analyzed due to the study was terminated prematurely due to slow to accrual and PI left the institution.
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] broken down by adverse event and CTCAE v4.0 grade of each event.
Outcome measures
Outcome data not reported
Adverse Events
TGR-1202
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place