What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy agents like gemcitabine and FOLFIRINOX can cause side effects such as nausea, vomiting, fatigue, diarrhea, and myelosuppression. Radiation therapy may lead to skin irritation, fatigue, and gastrointestinal issues. Targeted therapies, which may include agents like Telotristat Ethyl that aim to manage symptoms such as excessive bowel movements, can have side effects including nausea, headache, and abdominal pain. Overall, the side effects vary depending on the specific treatment regimen and the patient's overall health.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, primarily focusing on chemotherapy agents like gemcitabine and nab-paclitaxel, which target the cancer cells directly. For symptom management and improving quality of life, drugs like octreotide and lanreotide, which are somatostatin analogs, have been used to manage hormone-related symptoms in neuroendocrine tumors, including those of the pancreas. These drugs help control symptoms such as diarrhea, similar to the investigational use of Telotristat Ethyl, which aims to decrease bowel movements and promote weight stability in patients with advanced pancreatic cancer.

What other types of research exist?

One promising alternative is the use of novel dimethylpyridazine derivatives, which have shown efficacy in preclinical models for other cancers. Additionally, exploring the use of tropisetron, which has shown potential in alleviating tumor progression in colorectal cancer models, could be beneficial. These alternatives may offer new avenues for managing symptoms and improving treatment outcomes in pancreatic cancer patients.

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Nucleoside Analogues

Telotristat Ethyl for Advanced Pancreatic Cancer

Phase 2

Waitlist Available

Led By Walid Shaib, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

GROUP 1: Advanced stage pancreas cancer (recurrent/metastatic)

GROUP 1: Histologic or cytological diagnosis of recurrent or metastatic pancreas adenocarcinoma (PDAC) for first line chemotherapy treatment

Must not have

GROUP 1: Patients with chronic constipation

GROUP 1: Subjects with histology other than adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 3 months after study start

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well telotristat ethyl works in helping patients with advanced pancreatic cancer maintain their weight. The medication reduces bowel movements, which may help patients gain weight and better tolerate chemotherapy.

Who is the study for?

This trial is for adults with advanced pancreatic cancer that has spread and returned after treatment. They must have a certain level of blood cells, liver function, and kidney health; not be severely immunocompromised; able to swallow pills; not pregnant or breastfeeding; and willing to use contraception if sexually active.

What is being tested?

The study tests Telotristat Ethyl's ability to help patients maintain their weight during chemotherapy. Weight stability might improve tolerance to chemo and overall survival. Patients will also receive standard chemotherapy drugs Gemcitabine and Nab-paclitaxel.

What are the potential side effects?

Telotristat Ethyl may cause reduced bowel movements which could lead to weight gain. Standard chemo side effects can include fatigue, nausea, low blood cell counts, increased risk of infection, hair loss, numbness in fingers or toes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer is in an advanced stage or has spread.

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I have been diagnosed with recurrent or metastatic pancreatic cancer and need first-line chemotherapy.

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I have advanced pancreatic cancer and haven't had chemotherapy yet.

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My pancreatic cancer is in an advanced stage and cannot be surgically removed.

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I have lost 10% or more of my weight.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chronic constipation.

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My cancer is not adenocarcinoma.

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I currently have an infection.

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I have another active cancer besides non-melanoma skin cancer or a noninvasive carcinoma.

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I have heart problems like heart failure, chest pain, or irregular heartbeat.

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I am experiencing a recent blockage in my intestines.

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I have brain or spinal cord cancer spread.

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I have had an organ or tissue transplant before.

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My cancer is not adenocarcinoma.

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I am severely immune-compromised due to conditions other than steroid use, including HIV.

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I am experiencing a recent blockage in my intestines.

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I cannot swallow or take pills by mouth.

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I am severely immune-compromised due to conditions other than steroid use, including HIV.

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I currently have an infection.

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I have heart problems like heart failure, chest pain, or irregular heartbeat.

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I have fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 3 months after study start

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 3 months after study start

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months after study start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight stability

Secondary study objectives

Blood serotonin levels

Change in 24-hr urine 5-hydroxyindoleacetic acid (5-HIAA) levels

Change in serum 5-hydroxyindoleacetic acid (5-HIAA) levels

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)Experimental Treatment3 Interventions

Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Group 2 (gemcitabine/nab-paclitaxel)Active Control2 Interventions

Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Telotristat Ethyl

2017

Completed Phase 1

~20

Nab-paclitaxel

2014

Completed Phase 3

~1950

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and supportive care. Chemotherapy drugs like FOLFIRINOX and gemcitabine work by interfering with the DNA replication of cancer cells, thereby inhibiting their growth and proliferation. Targeted therapies, such as PARP inhibitors for BRCA-mutated cancers, specifically attack cancer cells with certain genetic mutations, sparing normal cells. Supportive care treatments, like Telotristat Ethyl, aim to manage symptoms and improve quality of life; for instance, Telotristat Ethyl decreases bowel movements, which can help stabilize weight and enhance the patient's ability to tolerate chemotherapy. These mechanisms are crucial for pancreatic cancer patients as they not only target the cancer but also address debilitating symptoms, thereby improving overall treatment outcomes and quality of life.

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