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Trial record 39 of 40 for:    somatostatin analogues | Neuroendocrine Tumors

Telotristat Etiprate for Carcinoid Syndrome Therapy (TELECAST)

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ClinicalTrials.gov Identifier: NCT02063659
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : September 25, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Condition or disease Intervention/treatment Phase
Carcinoid Syndrome Drug: Telotristat etiprate Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome
Actual Study Start Date : March 11, 2014
Actual Primary Completion Date : March 29, 2016
Actual Study Completion Date : March 29, 2016


Arm Intervention/treatment
Experimental: 250 mg Telotristat Etiprate
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.
Drug: Telotristat etiprate
Telotristat etiprate tablets
Other Name: LX1606

Drug: Placebo
Placebo-matching telotristat etiprate tablets

Experimental: 500 mg Telotristat Etiprate
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.
Drug: Telotristat etiprate
Telotristat etiprate tablets
Other Name: LX1606

Drug: Placebo
Placebo-matching telotristat etiprate tablets

Placebo Comparator: Placebo
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.
Drug: Placebo
Placebo-matching telotristat etiprate tablets




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period [ Time Frame: First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks) ]
    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.

  2. Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels [ Time Frame: Baseline and 12 Weeks ]
    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.

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period [ Time Frame: First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks) ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks [ Time Frame: Baseline and 12 weeks ]
    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.

  2. Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points [ Time Frame: Baseline and 12 Weeks ]
    Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.

  3. Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points [ Time Frame: Baseline and 12 Weeks ]
    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.

  4. Change From Baseline in Abdominal Pain Averaged Across All Time-Points [ Time Frame: Baseline and 12 Weeks ]
    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.

  5. Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points [ Time Frame: Baseline and 12 weeks ]
    The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.

  6. Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline [ Time Frame: Baseline and 12 Weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Documented history of carcinoid syndrome
  • Patient is able and willing to provide written informed consent prior to participation

Exclusion Criteria:

  • Presence of diarrhea attributed to any condition other than carcinoid syndrome.
  • Presence of 12 or more watery bowel movements per day
  • Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
  • Karnofsky Performance Status ≤ 60%
  • Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
  • A history of short bowel syndrome
  • History of constipation within 2 years of Screening
  • Life expectancy < 12 months from Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063659


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Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02063659     History of Changes
Other Study ID Numbers: LX1606.1-303-CS
LX1606.303 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
2013-001543-31 ( EudraCT Number )
First Posted: February 14, 2014    Key Record Dates
Results First Posted: September 25, 2017
Last Update Posted: February 26, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Syndrome
Malignant Carcinoid Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Adenocarcinoma
Carcinoma
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders