Phase I Trial of Combination of FOLFIRI and SOM 230
|ClinicalTrials.gov Identifier: NCT01434069|
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : December 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Tumor||Drug: SOM230C LAR Drug: FOLFIRI Infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies|
|Study Start Date :||September 2011|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Experimental: Combination Therapy: FOLFIRI and SOM 230
Treatment will be administered on an outpatient basis. FOLFIRI is administered by IV infusion every 2 weeks. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of > 10% from baseline.
SOM 230 will be administered as an intramuscular dose determined by the dosing schema, every 28 days.
Drug: SOM230C LAR
Participants will be given one LAR dose injected into the muscle of the buttocks by a study nurse about once every 28 days until unacceptable toxicity or progression of the disease.
Other Name: Pasireotide LARDrug: FOLFIRI Infusion
Standard therapy of FOLFIRI
Other Name: 5-Fluorouracil (5FU), leucovorin (LV), and irrinotecan
- Maximum Tolerated Dose (MTD) [ Time Frame: Average of 6 Months Per Participant ]To determine the maximum tolerated dose (using a standard 3+3 design), of SOM 230 and FOLFIRI.
- Number of Participants With Adverse Events (AEs) [ Time Frame: Average of 6 Months Per Participant ]Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
- Number of Participants With Tumor Response [ Time Frame: Average of 6 Months Per Participant ]Evaluate the frequency of tumor response by dose cohort according to the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434069
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Richard Kim, M.D.||H. Lee Moffitt Cancer Center and Research Institute|