CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Ibrutinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02575300
NCT02575300Phase 2Completed

Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Oct 14, 2015·Updated Sep 11, 2020

In Brief

A Phase 2 clinical trial evaluating Ibrutinib for Carcinoid Tumors and Pancreatic NET. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This is a prospective phase II open-label trial, stratifying patients equally into two cohorts consisting of carcinoid tumors and pancreatic neuroendocrine tumors (pNETs). The purpose of this study is to test any good and bad effects of the study drug called Ibrutinib. The study population will consist of adult patients with histologically confirmed low to intermediate grade NETs of the GI tract, lungs and unknown primary (carcinoid tumors) or pNETs. All patients must be confirmed to have advanced disease. The study will enroll up to 51 patients in two cohorts (30 carcinoid and 21 pNET patients).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPharmacyclics LLC.

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 14, 2015
Enrollment StartOct 9, 2015
Primary CompletionMar 26, 2019
Study CompletionNov 4, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.7 years ago

Interventions

Ibrutinibdrug

Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.