Neuroendocrine TumorsPhase 2NET-PACSNCT04713202
Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl
A Phase 2 study testing Telotristat ethyl and Peptide Receptor Radionuclide Therapy in people with Neuroendocrine Tumors and Carcinoid Syndrome, run by Chandrikha Chandrasekhara at 1 site in United States.
Trial summary
The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Carcinoid Syndrome, Diarrhea
- What is being tested?
- Telotristat ethyl and Peptide Receptor Radionuclide Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Males and females, aged 18 and older
- Histologically-confirmed neuroendocrine tumor (GI or other primary)
- Presence of somatostatin receptors as by either Ga-68 dotatate imaging or Octreoscan or comparable method, which is a requirement for PRRT (Lutathera ®). Disease does not need to be measurable per RECIST since it is not uncommon to have non-target lesions but not meet criteria for RECIST as long as presence of somatostatin receptors can be demonstrated. NOTE: Patients undergoing other types of PRRT would not be eligible for this clinical trial.
- Eligible for treatment with PRRT (Lutathera®) according to institutional practice and product label.
- Patient with current or prior history of symptomatic carcinoid syndrome or carcinoid diarrhea as per investigator assessment. Note: prior history and current controlled carcinoid patients are eligible.
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- Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
- Life expectancy greater than 12 weeks as per investigator opinion
- ECOG performance status 0-2
- Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum βhCG) within 7 days prior to study registration. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. See the protocol for WOCBP definition.
Who cannot join
- Surgery, radiotherapy, within 4 weeks; chemotherapy, or other investigational therapy within 2 weeks prior to study registration, or 5 half-lives of a drug, whichever is shorter.
- Uncontrolled congestive heart failure prior to study registration. Patients can be considered eligible if the disease is controlled at the date of randomization.
- Subject with another significant medical, psychiatric, or surgical conditions, currently uncontrolled by treatment, which may interfere with completion of the study as per investigator opinion.
- Women of childbearing potential (WOCBP), must agree to use appropriate method(s) of contraception. Women are considered to be of childbearing potential unless are surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- WOCBP must agree to use appropriate method(s) of contraception from the time of informed consent until 7 months post-treatment completion. Complete abstinence is also an acceptable form of contraception.
- Men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception from the first dose of study drug until 4 months post-treatment completion. Complete abstinence is also an acceptable form of contraception.
- Telotristat ethyl tablets contain lactose as an excipient. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take telotristat ethyl.
- Concomitant medications: Any other herbal or alternative medicines being used as an anti-cancer treatment are not allowed. NOTE: if patient is receiving a drug that is a CYP3A4 substrate, strongly consider switching to an alternate drug if possible. The latter is more of a recommendation, not an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400
The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.
- Conditions
- Neuroendocrine Tumors, Carcinoid Syndrome, Diarrhea
- Being tested
- Telotristat ethyl, Peptide Receptor Radionuclide Therapy, Placebo
- Medical subject headings
- Neuroendocrine Tumors, Serotonin Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat ethylDrug
Telotristat Ethyl, 250mg
Peptide Receptor Radionuclide TherapyDrug
Also called PRRT
Peptide Receptor Radionuclide Therapy
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Telotristat Ethyl + PRRT | Experimental | Telotristat ethyl, 250 mg, PO, three times daily, continuous.
+ Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks Receives: Drug: Telotristat ethyl; Drug: Peptide Receptor Radionuclide Therapy |
| Placebo + PRRT | Placebo comparator | Placebo, PO, three times daily, continuous.
+ Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks Receives: Drug: Peptide Receptor Radionuclide Therapy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-QS global QoL Score
Feasibility of in-depth assessment of changes and improvement on treatment in patients undergoing treatment as determined by FACT-CS global QoL with PRRT using telotristat ethyl compared to placebo. The FACT-CS global QoL is the primary endpoint. Scores will be derived using FACIT guidelines and will range from 0 to 12 with higher scores denoting a better level of functioning.
A repeated measures ANOVA will be applied and statistical significance of fixed effects of treatment arm, time and treatment arm by time interaction will be assessed using a Wilks' Lambda Approximate F test.
Measured: From enrollment until completion of study therapy or subject withdrawal, up to six months
Secondary outcomes (6)
To describe and report from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.
Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL as measured by the identified FACT-CS scales. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.
Measured: From enrollment until completion of study therapy or subject withdrawal, up to six months
ATo report changes in patient reported outcomes (PRO) in the diarrhea domain in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL Diarrhea domain as measured by the identified FACT-CS scales. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.
Measured: From enrollment until completion of study therapy or subject withdrawal, up to six months
To report changes in patient reported outcomes (PRO) in the flushing domain in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL as measured by the identified FACT-CS scales in the flushing domain. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.
Measured: From enrollment until completion of study therapy or subject withdrawal, up to six months
To estimate the need of rescue short-acting somatostatin receptor antagonist in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Linear mixed effects regression model will be utilized to describe longitudinal changes in frequency of rescue short acting somatostatin receptor antagonist use. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.
Measured: From enrollment until completion of study therapy or subject withdrawal, up to six months
To estimate the weight-gain in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Linear mixed effects regression model will be utilized to describe longitudinal changes in weight. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.
Measured: From enrollment until completion of study therapy or subject withdrawal, up to six months
To estimate the changes in bowel movement frequency and/or consistency in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Linear mixed effects regression model will be utilized to describe longitudinal changes in frequency and/or changes in consistency of bowel movements. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.
Measured: From enrollment until completion of study therapy or subject withdrawal, up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start3 Mar 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: Funder decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chandrikha Chandrasekhara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chandrikha Chandrasekhara, Big Ten Cancer Research Consortium
- Investigators
- Chandrikha Chandrasekharan, MD, Principal investigator, University of IowaAl B Benson, MD, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713202
- Sponsor's protocol ID
- BTCRC-GI19-400
- Acronym
- NET-PACS
- Status last verified
- Feb 2023
- First submitted
- 14 Jan 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400
- ClinicalTrials.gov ID
- NCT04713202
- Acronym / sponsor ID
- NET-PACS / BTCRC-GI19-400
- Conditions
- Neuroendocrine Tumors, Carcinoid Syndrome, Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funder decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chandrikha ChandrasekharaUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telotristat Ethyl + PRRT | Experimental | Drug: Telotristat ethyl, Drug: Peptide Receptor Radionuclide TherapyTelotristat ethyl, 250 mg, PO, three times daily, continuous. + Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks |
| Placebo + PRRT | Placebo comparator | Drug: Peptide Receptor Radionuclide Therapy, Other: PlaceboPlacebo, PO, three times daily, continuous. + Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Males and females, aged 18 and older
- Histologically-confirmed neuroendocrine tumor (GI or other primary)
- Presence of somatostatin receptors as by either Ga-68 dotatate imaging or Octreoscan or comparable method, which is a requirement for PRRT (Lutathera ®). Disease does not need to be measurable per RECIST since it is not uncommon to have non-target lesions but not meet criteria for RECIST as long as presence of somatostatin receptors can be demonstrated. NOTE: Patients undergoing other types of PRRT would not be eligible for this clinical trial.
- Eligible for treatment with PRRT (Lutathera®) according to institutional practice and product label.
Key exclusion criteria (8 listed)
- Surgery, radiotherapy, within 4 weeks; chemotherapy, or other investigational therapy within 2 weeks prior to study registration, or 5 half-lives of a drug, whichever is shorter.
- Uncontrolled congestive heart failure prior to study registration. Patients can be considered eligible if the disease is controlled at the date of randomization.
- Subject with another significant medical, psychiatric, or surgical conditions, currently uncontrolled by treatment, which may interfere with completion of the study as per investigator opinion.
- Women of childbearing potential (WOCBP), must agree to use appropriate method(s) of contraception. Women are considered to be of childbearing potential unless are surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- WOCBP must agree to use appropriate method(s) of contraception from the time of informed consent until 7 months post-treatment completion. Complete abstinence is also an acceptable form of contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telotristat ethylTelotristat Ethyl, 250mg | Drug | Telotristat Ethyl + PRRT |
| Peptide Receptor Radionuclide TherapyAlso: PRRTPeptide Receptor Radionuclide Therapy | Drug | Placebo + PRRT, Telotristat Ethyl + PRRT |
| PlaceboPlacebo | Other | Placebo + PRRT |
Primary outcome
FACT-QS global QoL Score
Time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months
Feasibility of in-depth assessment of changes and improvement on treatment in patients undergoing treatment as determined by FACT-CS global QoL with PRRT using telotristat ethyl compared to placebo. The FACT-CS global QoL is the primary endpoint. Scores will be derived using FACIT guidelines and will range from 0 to 12 with higher scores denoting a better level of functioning. A repeated measures ANOVA will be applied and statistical significance of fixed effects of treatment arm, time and treatment arm by time interaction will be assessed using a Wilks' Lambda Approximate F test.
6 secondary outcomes
To describe and report from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.
Time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months
ATo report changes in patient reported outcomes (PRO) in the diarrhea domain in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months
To report changes in patient reported outcomes (PRO) in the flushing domain in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months
To estimate the need of rescue short-acting somatostatin receptor antagonist in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months
To estimate the weight-gain in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months
To estimate the changes in bowel movement frequency and/or consistency in patients undergoing PRRT receiving telotristat ethyl versus placebo.
Time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandrikha Chandrasekharan, MD principal investigator
University of Iowa
Al B Benson, MD study chair
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telotristat ethyl and Peptide Receptor Radionuclide Therapy in people with Neuroendocrine Tumors and Carcinoid Syndrome, run by Chandrikha Chandrasekhara at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-QS global QoL Score (time frame: From enrollment until completion of study therapy or subject withdrawal, up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.