Clinical trialPhase 2Completed
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas
- Outcome
- Results posted; single-arm, no comparison
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 1 February 2011
- Ended
- 2 March 2023
- Enrollment
- 29 participants
- Sites
- 2
- Primary outcomes
- Progression-free Survival (PFS) at One Year
- Sponsor type
- Academic / other
- Results posted
- 18 January 2022
- Last update
- 6 March 2023
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Results
- Primary endpoint
- Results posted; single-arm, no comparisonAs posted on ClinicalTrials.gov ↗, registry record of 6 March 2023
- PFS
- Progression-free Survival (PFS) at One YearPasireotide LAR Treatment: 11 (7.6 to 16), n = 28Values: median months, 95% Confidence IntervalTime frame: 12 monthsNo analysis posted for this outcome (outcome 1)
- Participants
- Pasireotide LAR Treatment: 29 started, 28 completed
- Serious adverse events
- Pasireotide LAR Treatment: 12 of 29Participants with at least one serious adverse event, of those at risk, as posted
2 secondary outcomes
- ORR · Overall Radiographic Response Rate (ORR)
- Partial Response: Pasireotide LAR Treatment 4, n=28 [percentage of participants] (first of 3 rows)
- Adverse Events Possibly Related to Study Treatment
- Pasireotide LAR Treatment 42, n=29 [events]
Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.
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Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
This is a multi-institutional, prospective phase II open-label trial. The investigational drug used in this study is pasireotide 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. Safety and efficacy will be assessed throughout the treatment period.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) at One Year [12 months]. Median, months (95% Confidence Interval). Pasireotide LAR Treatment (n=28): 11 (7.6 to 16).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Radiographic Response Rate (ORR) [Up to 48 months]. Number, percentage of participants. Partial Response: Pasireotide LAR Treatment (n=28): 4. Stable Disease: Pasireotide LAR Treatment (n=28): 60. Progressive Disease: Pasireotide LAR Treatment (n=28): 36.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Adverse Events Possibly Related to Study Treatment [Up to 48 months]. Number, events. Pasireotide LAR Treatment (n=29): 42.