Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
|Neuroendocrine Tumors Carcinoid Tumors||Drug: Pasireotide Long Acting Release (LAR)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas|
- Rate of Progression-free Survival (PFS) at One Year [ Time Frame: 12 months ]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.
- Median Overall Survival (OS) [ Time Frame: Up to 48 months ]OS: The date of first study treatment to the date of death due to any cause.
- Overall Radiographic Response Rate (ORR) [ Time Frame: Up to 48 months ]Complete response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. This must be confirmed by repeat assessment at no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
- Occurrence of Adverse Events Possibly Related to Study Treatment [ Time Frame: Up to 48 months ]Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
|Experimental: Treatment phase||
Drug: Pasireotide Long Acting Release (LAR)
Intramuscular injection of Pasireotide LAR
Other Name: SOM 230
This is a multi-institutional, prospective phase II open-label trial.
The investigational drug used in this study is pasireotide LAR 60mg. 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. Safety and efficacy will be assessed throughout the treatment period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253161
|United States, California|
|Stanford Cancer Institute|
|Stanford, California, United States, 94305|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jonathan Strosberg, M.D.||H. Lee Moffitt Cancer Center and Research Institute|