Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02063659 | Telotristat Etiprate for Carcinoid Syndrome Therapy | PHASE3 | COMPLETED | 76 | — | — | Mar 11, 2014 | Mar 29, 2016 | Feb 26, 2018 | 50 | United States, Australia +9 |
| NCT02026063 | Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms | PHASE3 | COMPLETED | 124 | — | — | Jan 14, 2014 | Sep 12, 2018 | Sep 17, 2019 | 43 | United States, Australia +10 |
| NCT01677910 | TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) | PHASE3 | COMPLETED | 135 | — | — | Jan 8, 2013 | Mar 21, 2016 | Feb 27, 2018 | 75 | United States, Australia +10 |
| NCT01104415 | Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome | PHASE2 | COMPLETED | 15 | — | — | Jun 15, 2010 | Feb 12, 2014 | Mar 15, 2019 | 10 | Germany, United Kingdom |
| NCT00853047 | Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy | PHASE2 | COMPLETED | 23 | — | — | Mar 1, 2009 | Jun 1, 2014 | Dec 26, 2018 | 9 | United States |
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug.
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment.
| Arm | Type | Description |
|---|---|---|
| 250 mg Telotristat Etiprate | EXPERIMENTAL | Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period. |
| 500 mg Telotristat Etiprate | EXPERIMENTAL | Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period. |
| Placebo | PLACEBO_COMPARATOR | Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period. |
| Telotristat Etiprate Open-Label Extension | EXPERIMENTAL | Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks. |
| Telotristat etiprate - Core Phase | EXPERIMENTAL | Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period. |
| Telotristat etiprate - Extension Period | EXPERIMENTAL | Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit. |
| Telotristat Etiprate 150 mg Core Phase | EXPERIMENTAL | Telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Telotristat Etiprate 250 mg Core Phase | EXPERIMENTAL | Telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Telotristat Etiprate 350 mg Core Phase | EXPERIMENTAL | Telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Telotristat Etiprate 500 mg Core Phase | EXPERIMENTAL | Telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Placebo Core Phase | EXPERIMENTAL | Placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period. |
| Telotristat Etiprate Open-Label Extension Phase | EXPERIMENTAL | Telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily). |
| Name | Type | Description |
|---|---|---|
| Telotristat etiprate | DRUG | Telotristat etiprate tablets |
| Placebo | DRUG | Placebo-matching telotristat etiprate tablets |
| Placebo-matching telotristat etiprate | DRUG | Placebo-matching telotristat etiprate tablets. |
| Octreotide LAR Depot | DRUG | A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month. |
Inclusion Criteria: * Patients ≥ 18 years of age * All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit. * Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor * Documen...