Clinical trialPhase 1Completed
Phase I Trial of Combination of FOLFIRI and SOM 230
Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- September 2011
- Expected end
- December 2015
- Enrollment
- 16 participants
- Sites
- 1
- Primary outcomes
- Maximum Tolerated Dose (MTD)
- Sponsor
- Other
- Results posted
- No
- Last update
- 24 December 2015
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.
Detailed description public domain (ClinicalTrials.gov)
The goal of this clinical research study is to learn if the study drug SOM 230, also known as Pasireotide long-acting release (LAR), in addition to standard therapy of FOLFIRI (5FU, leucovorin, and irrinotecan) can shrink or slow the growth of gastrointestinal malignancies. The safety of this drug in combination with standard chemotherapy (FOLFIRI) will also be studied. The participant's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.