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

NCT04713202 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: BTCRC-GI19-400
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  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.

  From enrollment until completion of study therapy or subject withdrawal, up to six months

Study Arms (2)

Telotristat Ethyl + PRRT

EXPERIMENTAL

Telotristat ethyl, 250 mg, PO, three times daily, continuous. \+ Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks

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

Drug: Peptide Receptor Radionuclide Therapy; Other: Placebo

Interventions

Telotristat ethyl DRUG

Telotristat Ethyl, 250mg

Telotristat Ethyl + PRRT

Peptide Receptor Radionuclide Therapy DRUG

Peptide Receptor Radionuclide Therapy

Also known as: PRRT

Placebo + PRRT; Telotristat Ethyl + PRRT

Placebo OTHER

Placebo

Placebo + PRRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chandrikha Chandrasekhara: lead

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Serotonin Syndrome; Diarrhea

Interventions

telotristat ethyl

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chandrikha Chandrasekharan, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Al B Benson, MD

  Northwestern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor of Internal Medicine - Hematology, Oncology and Blood and Marrow Transplantation

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: March 3, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

US (1)