Overview

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

Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Big Ten Cancer Research Consortium
Chandrikha Chandrasekhara
Collaborator:
TerSera Therapeutics LLC
Criteria
Inclusion Criteria:

- 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
exclusion 4 for WOCBP definition.

Exclusion Criteria:

- 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.