Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer (NCT03910387) | Clinical Trial Compass
CompletedPhase 2
Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer
United States23 participantsStarted 2019-04-17
Plain-language summary
This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* GROUP 1 (Telotristat ethyl treatment group): Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
* GROUP 1 (Telotristat ethyl treatment group): Weight loss of 10% or more.
* GROUP 1 (Telotristat ethyl treatment group): Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 14 days prior to registration.
* GROUP 1 (Telotristat ethyl treatment group): Histologic or cytological diagnosis of recurrent or metastatic pancreas adenocarcinoma (PDAC) who present for first line chemotherapy treatment for metastatic disease.
* GROUP 1 (Telotristat ethyl treatment group): Advanced stage pancreas cancer (recurrent/metastatic).
* GROUP 1 (Telotristat ethyl treatment group): Measurable disease determined using guidelines of Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Baseline tumor assessment should be performed using high resolution computed tomography (CT) scans or magnetic resonance imaging (MRI).
* GROUP 1 (Telotristat ethyl treatment group): Prior systemic therapy (adjuvant or neoadjuvant setting are acceptable) if disease progressed or recurred within at least 3 months after treatment.
* GROUP 1 (Telotristat ethyl treatment group): Estimated life expectancy of \> 12 weeks, as assessed by the site investigator.
* GROUP 1 (Telotristat ethyl treatme…
What they're measuring
1
Weight Stability
Timeframe: Baseline up to 3 months after study start