Progression-free Survival (PFS) at One Year
| Group | Value (months) |
|---|---|
| Pasireotide LAR Treatment | 11 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
NCT012531611 Feb 2011 to 2 Mar 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Pasireotide LAR Treatment
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Outcomes the sponsor listed as primary.
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.
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.
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).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| Pasireotide LAR Treatment | 11 |
| Group | Value (percentage of participants) |
|---|---|
| Pasireotide LAR Treatment | 4 |
| Group | Value (events) |
|---|---|
| Pasireotide LAR Treatment | 42 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pasireotide LAR TreatmentThe investigational drug used in this study is pasireotide long acting release (LAR) 60 mg. Pasireotide Long Acting Release (LAR): 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. | 6 / 29 | 12 / 29 | 28 / 29 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Clinical trial · 2015
Cives et al. 2015Endocrine-related cancercited by 74
PMID 25376618PMC4643672DOI 10.1530/erc-14-0360PUB-25376618
Who could join, as posted.
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