Trial Outcomes & Findings for Telotristat With Lutathera in Neuroendocrine Tumors (NCT NCT04543955)
NCT ID: NCT04543955
Last Updated: 2023-06-27
Results Overview
Progression-free survival at 20 months.
TERMINATED
PHASE2
1 participants
20 months
2023-06-27
Participant Flow
Participant milestones
| Measure |
Arm 1: Low-Dose Telotristat
Participants in this group will receive 750mg Telotristat per day.
Telotristat (Low-Dose): Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.
|
Arm 2: High-Dose Telotristat
Participants in this group will receive 1500mg Telotristat per day.
Telotristat (High-Dose): Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Low-Dose Telotristat
Participants in this group will receive 750mg Telotristat per day.
Telotristat (Low-Dose): Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.
|
Arm 2: High-Dose Telotristat
Participants in this group will receive 1500mg Telotristat per day.
Telotristat (High-Dose): Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.
|
|---|---|---|
|
Overall Study
Company cancelled study
|
1
|
0
|
Baseline Characteristics
Telotristat With Lutathera in Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Arm 1: Low-Dose Telotristat
n=1 Participants
Participants in this group will receive 750mg Telotristat per day.
Telotristat (Low-Dose): Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.
|
Arm 2: High-Dose Telotristat
Participants in this group will receive 1500mg Telotristat per day.
Telotristat (High-Dose): Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=113 Participants
|
—
|
1 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=113 Participants
|
—
|
1 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=113 Participants
|
—
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
—
|
0 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=113 Participants
|
—
|
1 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 20 monthsPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Progression-free survival at 20 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Overall response rate using RECIST v1.1 at 6 and 12 months after therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Median progression-free survival.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Levels of urinary 5-Hydroxyindoleacetic acid (5-HIAA) will be measured at baseline and 12 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 monthPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients.It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items.Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 monthPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
The Quality of Life GI Neuroendocrine Tumor survey (QLQ-GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organised into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Low-Dose Telotristat
Arm 2: High-Dose Telotristat
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