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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months after study start
Awards & highlights
Study Summary
This trial will study how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight stability
Secondary outcome measures
Blood serotonin levels
Change in 24-hr urine 5-hydroxyindoleacetic acid (5-HIAA) levels
Change in serum 5-hydroxyindoleacetic acid (5-HIAA) levels
+5 moreTrial 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
~2070
Telotristat Ethyl
2017
Completed Phase 1
~20
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,427 Total Patients Enrolled
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,510 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,467 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for more than 12 weeks.I have been active and mostly self-sufficient in the last 2 weeks.I had radiation therapy more than 2 weeks ago.I had radiation therapy, but it was over 2 weeks ago.My cancer is not adenocarcinoma.I have chronic constipation.My cancer is not adenocarcinoma.Your white blood cell count is at least 1,500 per cubic millimeter.My pancreatic cancer is in an advanced stage or has spread.I currently have an infection.I have another active cancer besides non-melanoma skin cancer or a noninvasive carcinoma.I have heart problems like heart failure, chest pain, or irregular heartbeat.Your creatinine levels are less than or equal to 1.5 mg/dL.I am experiencing a recent blockage in my intestines.I have brain or spinal cord cancer spread.My condition worsened or came back 3 months after my last treatment.Your bilirubin level is less than or equal to 1.5 mg/dL.I have had an organ or tissue transplant before.I am severely immune-compromised due to conditions other than steroid use, including HIV.You are expected to live for more than 12 weeks.Your platelet count is 100,000/mm³ or higher.Your AST levels in the blood are not too high, unless you have cancer that has spread to the liver.I am experiencing a recent blockage in my intestines.Your liver function tests should show normal levels of alanine aminotransferase, unless you have liver metastases, in which case it can be slightly higher but still within a certain limit.I have been diagnosed with recurrent or metastatic pancreatic cancer and need first-line chemotherapy.You have a measurable tumor according to specific medical guidelines.Your hemoglobin level is at least 8 grams per deciliter.I cannot swallow or take pills by mouth.I've been mostly active and able to care for myself in the last 2 weeks.I am severely immune-compromised due to conditions other than steroid use, including HIV.I have advanced pancreatic cancer and haven't had chemotherapy yet.I currently have an infection.I have heart problems like heart failure, chest pain, or irregular heartbeat.My pancreatic cancer is in an advanced stage and cannot be surgically removed.I have fluid buildup in my abdomen.I have lost 10% or more of my weight.My condition worsened or came back 3 months after my last treatment.Your albumin levels are at least 2 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 (gemcitabine/nab-paclitaxel)
- Group 2: Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities to become involved in this clinical experiment?
"That is correct. As evidenced by the information posted on clinicaltrials.gov, this clinical trial currently recruiting patients to enroll in it began its search for volunteers on April 17th 2019 and was last modified on April 22nd 2022. 80 participants are needed between 3 different study sites."
Answered by AI
What condition does Telotristat Ethyl typically treat?
"Telotristat Ethyl is an effective therapeutic measure for neoplasm metastasis, acute pyelonephritis(apn), and diarrhea."
Answered by AI
Is Telotristat Ethyl a risk-free option for patients?
"The safety of Telotristat Ethyl received a rating of 2 on our scale due to the lack of data demonstrating efficacy, despite multiple rounds of clinical trials verifying its security."
Answered by AI
Could you provide a synopsis of any earlier trials involving Telotristat Ethyl?
"At present, 1139 clinical trials concerning Telotristat Ethyl are underway and 326 of them have entered Phase 3. Of the 59646 trial sites, most are in Shanghai; however there is also a global presence for this medication's research."
Answered by AI
How many individuals are partaking in this research experiment?
"Affirmative. The clinicaltrials.gov website reveals that this trial, which initially went public on April 17th 2019, is recruiting now. For the study to be successful it needs 80 individuals from 3 different medical centres to join."
Answered by AI
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