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Enzyme Inhibitor
Telotristat Etiprate for Neuroendocrine Neoplasm
Phase 2
Recruiting
Led By Anthony Shields
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well telotristat etiprate works in treating neuroendocrine neoplasm. Telotristat etiprate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying the changes within the tumor cells may help doctors better understand how tumors respond to treatment with telotristat etiprate.
Eligible Conditions
- Neuroendocrine Neoplasm
- Carcinoid Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The proportion of patients who achieved maximum standardized uptake value (SUVmax) reduction of 20% or more
Secondary study objectives
Change in mean standardized uptake value (SUVmean)
Neuroendocrine tumors visibility
Tumoral calcinosis
+1 moreSide effects data
From 2013 Phase 2 trial • 59 Patients • NCT0145605213%
Colitis ulcerative
8%
Abdominal pain
8%
Diarrhoea
8%
Dyspepsia
8%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Low Dose Telotristat Etiprate
High Dose Telotristat Etiprate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (AMT-PET, telotristat etiprate)Experimental Treatment4 Interventions
Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat etiprate treatment. Participants receive telotristat etiprate PO TID for 9-14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telotristat Etiprate
2012
Completed Phase 2
~60
Positron Emission Tomography
2011
Completed Phase 2
~2200
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Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
164 Previous Clinical Trials
9,242 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,995 Total Patients Enrolled
Anthony ShieldsPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
2 Previous Clinical Trials
8 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot be taking certain medications for cancer treatment, including targeted agents or chemotherapy drugs. If you have taken these medications in the past, you must have stopped using them at least one month ago.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AMT-PET, telotristat etiprate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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