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Telotristat (High-Dose) for Neuroendocrine Tumors

Phase 2
Waitlist Available
Led By Aman Chauhan, MD
Research Sponsored by Aman Chauhan
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 6 and 12 months
Awards & highlights

Study Summary

This trial will test whether Telotristat increases the efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Median Progression-Free Survival (PFS)
Overall Response Rate (ORR)
Quality of Life (QLQ-C30)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: High-Dose TelotristatExperimental Treatment1 Intervention
Participants in this group will receive 1500mg Telotristat per day.
Group II: Arm 1: Low-Dose TelotristatExperimental Treatment1 Intervention
Participants in this group will receive 750mg Telotristat per day.

Find a Location

Who is running the clinical trial?

Aman ChauhanLead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
Lowell Anthony, MDLead Sponsor
2 Previous Clinical Trials
27 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
27 Patients Enrolled for Neuroendocrine Tumors
TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,448 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
60 Patients Enrolled for Neuroendocrine Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still looking to enroll participants in this analysis?

"Clinicaltrials.gov denotes that this trial is actively searching for participants, with the original posting on July 19th 2021 and the latest edit made on November 10th 2022."

Answered by AI

Does the research encompass individuals aged 30 and above?

"According to the inclusion criteria, this trial only includes people between 18 and 100 years old. There are 15 clinical trials for minors below 18 and 167 studies that target patients over 65 years of age."

Answered by AI

What type of individuals is this clinical trial targeting?

"This medical trial requires participants to meet two prerequisites: they must have previously failed a systemic cancer treatment for their neuroendocrine tumors, and possess an ECOG performance status of 2 or lower. These conditions apply to all 70 individuals aged 18-100 who are being recruited."

Answered by AI

How many participants may join the experiment?

"Affirmative. According to clinicaltrials.gov, this research study is currently seeking participants. It was first published on July 19th 2021 and last modified on November 10th 2022 with the intent of enrolling 70 individuals at one site only."

Answered by AI

Can you elaborate on what other studies have been conducted using high-dose telotristat?

"Currently, 4 clinical trials are underway for Telotristat (High-Dose). One of these is at Phase 3. While the majority of studies occur in Houston, Texas; 6 sites across the US are running research with this drug."

Answered by AI

What potential risks could be associated with Telotristat (High-Dose) consumption?

"The drug Telotristat (High-Dose) has been assigned a safety score of 2, as it is currently undergoing Phase 2 trials where limited data exists in regards to its efficacy but some evidence supports its security."

Answered by AI
~0 spots leftby Apr 2025