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TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Phase 3 trial testing Telotristat etiprate in Carcinoid Syndrome in 135 participants. Completed in 21 March 2016.
| Lead sponsor | Lexicon Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 8 January 2013 |
| Primary completion | 21 March 2016 |
| Estimated completion | 21 March 2016 |
| Sites | 75 locations across France, Italy, Netherlands, Belgium, Sweden, United Kingdom, Germany, Israel |
Lexicon Pharmaceuticals — full company profile →
18 and older, any sex, with Carcinoid Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.623 | ± 0.8275 |
| 250 mg Telotristat Etiprate | -1.433 | ± 1.3652 |
| 500 mg Telotristat Etiprate | -1.455 | ± 1.3098 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 39 | |
| 250 mg Telotristat Etiprate | 37 | |
| 500 mg Telotristat Etiprate | 42 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 11.350 | ± 35.0346 |
| 250 mg Telotristat Etiprate | -40.134 | ± 84.7663 |
| 500 mg Telotristat Etiprate | -57.519 | ± 82.3273 |
Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.164 | ± 1.1572 |
| 250 mg Telotristat Etiprate | -0.296 | ± 1.3097 |
| 500 mg Telotristat Etiprate | -0.525 | ± 1.3413 |
Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.226 | ± 1.1601 |
| 250 mg Telotristat Etiprate | -0.489 | ± 1.4423 |
| 500 mg Telotristat Etiprate | -0.333 | ± 1.1784 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Telotristat Etiprate Open-Label Extension | 110 |
Time frame: First dose of study drug to within 30 days of last dose of study drug (Up to 72.2 Weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | 250 mg Telotristat Etiprate | 500 mg Telotristat Etiprate | Telotristat Etiprate Open-… |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — |
| Investigation | Investigations | — | — | — | — |
| Radiotherapy | Surgical and medical procedures | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Faecaloma | Gastrointestinal disorders | — | — | — | — |
| Peritonitis | Infections and infestations | — | — | — | — |
| Desseminated intravascular coagulation | Blood and lymphatic system disorders | — | — | — | — |
| Carcinoid heart disease | Cardiac disorders | — | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — | — |
| Cardiovascular disorder | Cardiac disorders | — | — | — | — |
| Carcinoid syndrome | Endocrine disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Ileus | Gastrointestinal disorders | — | — | — | — |
| Rectal hemorrhage | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Disease progression | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Bile duct stenosis | Hepatobiliary disorders | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Cachexia | Metabolism and nutrition disorders | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Reaction | System | Placebo | 250 mg Telotristat Etiprate | 500 mg Telotristat Etiprate | Telotristat Etiprate Open-… |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Gamma-glutamyl transferase increased | Investigations | — | — | — | — |
| Depressed mood | Psychiatric disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Flushing | Vascular disorders | — | — | — | — |
| Decreased interest | Psychiatric disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Alanine amino transferase increased | Investigations | — | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — | — |
| Memory impairment | Nervous system disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
Most-reported serious reactions: Abdominal Pain, Investigation, Radiotherapy, General physical health deterioration, Tumour pain, Faecaloma, Peritonitis, Desseminated intravascular coagulation.
Data from ClinicalTrials.gov NCT01677910 adverse events section.
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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