NCT01253161|CompletedPhase 2ResultsDMCFDA Drug
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Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas
Sponsor study identifier
Secondary identifiers
OTHER · Novartis Pharmaceuticals
interventional
29
1 country
2
Study Start
February 1, 2011
Actual (reported)Primary Completion
October 6, 2021
Actual (reported)Study Completion
March 2, 2023
Actual (reported)The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug will also be studied. The patient'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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2010
Actual (reported)December 3, 2010
Actual (reported)February 1, 2011
Actual (reported)October 6, 2021
Actual (reported)January 18, 2022
Actual (reported)March 2, 2023
Actual (reported)Progression-free Survival (PFS) at One Year
PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
12 months
Overall Radiographic Response Rate (ORR)
Up to 48 months
Adverse Events Possibly Related to Study Treatment
Up to 48 months
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stanford Cancer Institute
Stanford, California, 94305, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Cives M, Kunz PL, Morse B, Coppola D, Schell MJ, Campos T, Nguyen PT, Nandoskar P, Khandelwal V, Strosberg JR. Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors. Endocr Relat Cancer. 2015 Feb;22(1):1-9. doi: 10.1530/ERC-14-0360. Epub 2014 Nov 6.
Jonathan Strosberg, M.D.
H. Lee Moffitt Cancer Center and Research Institute
29 participants (actual enrollment reported by the registry).
First Submitted
November 30, 2010
First Posted
December 3, 2010
Study Start
February 1, 2011
Actual (reported)A Study of Axitinib in Advanced Carcinoid Tumors
Contact the study team to confirm eligibility.
Primary Completion
October 6, 2021
Actual (reported)Study Completion
March 2, 2023
Actual (reported)Last Updated
March 6, 2023
Results First Posted
January 18, 2022
Record last verified: 2023-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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