AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With Metastatic Well Differentiated Neuroendocrine Neoplasm
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03453489|
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Carcinoid Syndrome Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm||Other: Carbon C 11 Alpha-methyltryptophan Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography Drug: Telotristat Etiprate||Phase 2|
I. To evaluate the effect of telotristat etiprate (telotristat ethyl) treatment in patients with advanced neuroendocrine tumors (NETs) using carbon C 11 alpha-methyltryptophan (alpha-[11C]methyl-?L-?tryptophan) (AMT)-?positron emission tomography (PET) as measured by changes in tumor maximum standardized uptake value (SUVmax).
I. Show that NETs will have increased AMT uptake on PET, as compared to surrounding non-tumor tissue at baseline.
II. Use compartmental modeling (in tumors with the left ventricle of the heart in the field-of-view) to measure change in AMT retention.
III. Measure change in AMT retention as mean standardized uptake value (SUVmean).
Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat etiprate treatment. Participants receive telotristat etiprate orally (PO) three times a day (TID) for 9-14 days.
After completion of study treatment, participants are followed up for 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monitoring Telotristat Ethyl Inhibition of Tryptophan Hydroxylase (TPH) in Neuroendocrine Tumors Using ?-[11C]Methyl-L-tryptophan (AMT)-PET|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Treatment (AMT-PET, telotristat etiprate)
Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat etiprate treatment. Participants receive telotristat etiprate PO TID for 9-14 days.
Other: Carbon C 11 Alpha-methyltryptophan
Other: Laboratory Biomarker Analysis
Procedure: Positron Emission Tomography
Drug: Telotristat Etiprate
- The proportion of patients who achieved maximum standardized uptake value (SUVmax) reduction of 20% or more [ Time Frame: Baseline up to follow up, assessed up to 3 months ]Will be reported with a one-sided, 90% confidence limit.
- Change in mean standardized uptake value (SUVmean) [ Time Frame: Baseline up to 3 months ]Will be reported as proportions with two-sided exact 95% confidence intervals. Paired t test will be used for pre-and post-treatment SUVs if normality assumption holds.
- Neuroendocrine tumors visibility [ Time Frame: At baseline ]Will be reported as proportions with two-sided exact 95% confidence intervals.
- Optimal time frame where tumoral AMT uptake peaks [ Time Frame: Up to 3 months ]Will use time-activity curves. Will be reported as proportions with two-sided exact 95% confidence intervals.
- Percent difference in carbon C 11 alpha-methyltryptophan (AMT) uptake between the tumor mass and background [ Time Frame: Up to 3 months ]Will be reported as proportions with two-sided exact 95% confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453489
|United States, Michigan|
|Wayne State University/Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Anthony F. Shields, M.D., PhD 313-576-8735 firstname.lastname@example.org|
|Principal Investigator: Anthony F. Shields, M.D., PhD.|
|Sub-Investigator: Csaba Juhasz, M.D., PhD.|
|Sub-Investigator: Philip A. Philip, M.D.|
|Sub-Investigator: Anteneh Tesfaye, M.D.|
|Sub-Investigator: Mohammed Al Hallak, M.D.|
|Principal Investigator:||Anthony Shields||Barbara Ann Karmanos Cancer Institute|