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Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs

Cancer Clinical Trial

Official title:
Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors

Clinical Trial Summary

The goal of this study is to establish maximum tolerated doses/recommended phase 2 dose (RP2D) of temozolomide (TMZ) and TAS-102 when these agents are used in combination and to evaluate the safety profile of this drug combination.

Clinical Trial Description

The study is a two part phase 1B clinical trial consisting of three study periods: a screening period of 14 days or less, a treatment period, and a safety follow-up period 30 days after treatment discontinuation. Part 1 is a dose finding phase with the objective to assess the safety and tolerability of the proposed drug combination and to identify the maximum tolerated dose (MTD) and a recommended phase 2 dose. Part 2 is an open-label expansion study, which will enroll patients with metastatic pNETs who have not been previously treated with chemotherapy. Part 2 will obtain further safety data of the proposed drug combination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02943733
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Terminated
Phase Phase 1
Start date August 22, 2017
Completion date January 31, 2022
View Details
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