Telotristat Ethyl for Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
M D Anderson Cancer Center, Houston, TX
Cancer+5 More
Telotristat Ethyl - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether telotristat ethyl is more effective than somatostatin analog therapy alone in treating patients with neuroendocrine tumor that has spread to other places in the body.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Neuroendocrine Tumors
  • Locally Advanced Neuroendocrine Neoplasm
  • Metastatic Neuroendocrine Neoplasm
  • Locally Advanced Well Differentiated Neuroendocrine Neoplasm
  • Metastatic Well Differentiated Neuroendocrine Neoplasm

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Telotristat Ethyl will improve 1 primary outcome and 8 secondary outcomes in patients with Cancer. Measurement will happen over the course of Baseline to 6 months.

Month 6
Change (significant change or non-significant change) in global longitudinal myocardial strain assessment of the left and right ventricle
Change in 6-minute walk test (6MWT)
Change in Carcinoid Valvular Heart Disease (CVHD) score
Change in high sensitivity troponin T
Change in plasma 5-HIAA levels
Change in quality of life questionnaire
Change in tricuspid annular plane systolic excursion (normal vs. abnormal)
Baseline to 6 months
Percent change in N-terminal pro B-type natriuretic peptide (NT-proBNP)
Up to 6 months
Incidence of adverse events

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm B (placebo, SSA)
Arm A (telotristat ethyl, SSA)
Placebo group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Telotristat Ethyl is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Arm A (telotristat ethyl, SSA)Patients receive telotristat ethyl PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.
Arm B (placebo, SSA)Patients receive placebo PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telotristat ethyl
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 3 and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 3 and 6 months for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are 18 years old or older. show original
Currently receiving stable-dose somatostatin analog (SSA) therapy defined as >= 2 months
You have received octreotide LAR at 30 mg every 4 weeks. show original
You have a history of carcinoid syndrome based on clinical parameters. show original
You are taking lanreotide depot at 120 mg every 4 weeks. show original
Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
Ability and willingness to provide written informed consent
You are of childbearing potential and must agree to use an adequate method of contraception during the study and for 30 days after the last dose of telotristat ethyl. show original
Childbearing potential is defined as those who have not undergone surgical sterilization (eg. documented hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy) or those who are not considered postmenopausal (defined as 12 months of spontaneous amenorrhea).
Adequate methods of contraception, defined as having a failure rate of < 1% per year, for patients or their partner include the following: condom with spermicidal gel, diaphragm with spermicidal gel, intrauterine device, surgical sterilization, vasectomy, oral contraceptive pill, depo-progesterone injections, progesterone implant (ie, Implanon), patch (Ortho Evra), NuvaRing, and abstinence. If a patient is not sexually active but becomes active, he or his partner should use medically accepted forms of contraception

Patient Q&A Section

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

Can cancer be cured?

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With better treatment and earlier detection, most patients with early-stage cancer can live a normal life for many years and, to a large degree, eliminate symptoms if the disease is detected early. However, patients over 70 years old are much more likely to have a fatal disease. The life expectancy for any individual depends on both the stage of cancer and the patient's ability to deal with the disease and with treatment, whereas the lifespan of the average patient is shortened by cancer compared with the average general population only by a small amount, typically about half a life.

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How many people get cancer a year in the United States?

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There are some significant racial differences, with blacks/African Americans having nearly half as many cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) but more lung cancer, oesophageal cancer, colorectal cancer, and melanoma. At present, the most common cancers in American women are breast cancer (around 11% of all cases), colorectal cancer (around 7%), ovarian cancer (around 2%), and lung cancer (around 2%); and in men, prostate cancer (around 5%) and colorectal cancer (around 4%).

Unverified Answer

What are common treatments for cancer?

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Cancer treatment in all its forms includes a wide range of non-drug remedies that are often used for adjuvant cancer treatment, cancer symptoms and pain, and pain from cancer treatment. Many patients also seek alternative treatment that does not have a high level of evidence of effectiveness, but many of these practices are also used for common ailments like arthritis and headaches, for which there is some evidence to support them. Patients of all races and sexes seek many of these treatments, making them both widely accessible and the subject of lively community debate.

Unverified Answer

What are the signs of cancer?

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Signs of cancer can include unexplained weight loss, pain and swelling with breast cancer, a lump or a cancerous lump, feeling tired, feeling thirsty, and feeling warm. The hands and feet are often painful. Symptoms can begin suddenly, and can develop rapidly, in a short period of time. Symptoms can be mistaken for common pains such as a cold, and in many cases they may recur regularly.

Unverified Answer

What causes cancer?

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Various types of cancer are caused by various factors, including toxins, infection and chemicals. Cancer is caused in some people by a number of different factors. Most cancer causes are inherited from a person's parents.

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What is cancer?

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Cancer is caused by environmental and genetic factors and has many possible symptoms. About half a million people are diagnosed with an active cancer every year. People can make a difference to cancer. Cancer is a cause of death and disability for many people.

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Who should consider clinical trials for cancer?

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Cancer patients are considered research participants and/or clinical research subjects, but are also members of the public by virtue of their cancer condition. As such, it is important to consider the perspectives of participants in the clinical research process. The patients' value-laden priorities should be sought out when making decisions about clinical research for cancer.

Unverified Answer

What is the average age someone gets cancer?

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In 2005 and in 2006, the average age diagnosed as of any cancer in Australia was 68 years, with the exception of brain and brainstem cancer, where the average age diagnosed was 61.6 years. This shows brain and brainstem cancers are diagnosed later than other cancers, with the exception of breast cancer being the most common cancer diagnosed. Breast cancer was an exception in that it was diagnosed earlier with the average age diagnosed as 61 years. This may be an anomaly and is most likely due to increased screening programs as well as increased awareness of breast cancer.

Unverified Answer

Is telotristat ethyl typically used in combination with any other treatments?

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Telotristat ethyl is occasionally used in combination with gemcitabine in patients with advanced pancreatic cancer. However, the optimal timing of its use and the role of teltristat in the treatment of advanced pancreatic cancer remain to be clearly defined.

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How does telotristat ethyl work?

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Results from a recent clinical trial of this Phase II study suggest that treatment with telotristat etil does not affect survival. We intend to continue evaluation of telotristat etil in patients with advanced or metastatic pancreatic adenocarcinoma.

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What is the survival rate for cancer?

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There is very high survival rates for some types of cancer, including testicular cancer (the most chemosensitive of all cancers), prostate cancer and, of course, breast cancer. However, survival rates are rather low, especially for testicular cancer and, to a lesser degree, lung cancer. Survival rates for colon cancer are among the lowest for any cancer. This pattern can be explained by the various types of cancer, their propensity to spread to other tissues or to other parts of the body (in the case of colon cancer, to lymph nodes or to liver), and/or the types of treatments available and patients’ willingness or ability to get treatment.

Unverified Answer

Does telotristat ethyl improve quality of life for those with cancer?

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Overall, the treatment was well tolerated. In the subset of patients with advanced pancreatic and some stomach cancer, telotristat ethyl showed some potential improvement in time-to-progression and overall survival compared with placebo alone. Clinical trial registered with www.clinicaltrials.gov (NCT01209564).

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