Trials / Terminated
TerminatedNCT02943733
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAS-102 | Anti-metabolite agent, taken orally. |
| DRUG | Temozolomide | Oral chemotherapy drug. |
| DRUG | Filgrastim | Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy. |
| DRUG | Pegfilgrastim | Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy. |
Timeline
- Start date
- 2017-08-22
- Primary completion
- 2020-11-07
- Completion
- 2022-01-31
- First posted
- 2016-10-25
- Last updated
- 2022-09-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02943733. Inclusion in this directory is not an endorsement.