Clinical trialPhase 1Terminated
Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs
Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors
- Outcome
- Stopped earlyclosed per sponsor request, for slow enrollment (Enrollment)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 22 August 2017
- Expected end
- 31 January 2022
- Enrollment
- 18 participants
- Sites
- 1
- Primary outcomes
- Part 1: Maximum Tolerated Dose (MTD) of TAS-102; Part 2: Overall Response Rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 23 September 2022
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.