Phase 3
Completed N=110
Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease
Symptomatic Refractory Resistant Carcinoid Disease
Source: ClinicalTrials.gov NCT00690430 ↗
Enrolled (actual)
110
Serious AEs
34.4%
Results posted
Jul 2013
Primary outcomePrimary: Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment. — 13.5; 28.2; 100; 20.0 Percentage of Participants
Summary
The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment. |
13.5; 28.2; 100; 20.0; 50; 0.0 | — |
| SECONDARY Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment. |
-23.5; -38.4; -44.2; -22.9; -25.1; -36.5 | — |
| SECONDARY Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment. |
-41.0; -52.8; -48.4; 47.2; -42.1; -49.4 | — |
| SECONDARY Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response. |
— | — |
| SECONDARY Objective Tumor Response Rate Assessed by Investigator |
2.0; 3.8 | — |
| SECONDARY Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria |
62.7; 46.2 | — |
| SECONDARY Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire |
— | — |
| SECONDARY Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression |
— | — |
| SECONDARY Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response |
— | — |
| SECONDARY Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements |
— | — |
Eligibility Criteria
Inclusion criteria
- Male or female patients aged 18 or greater
- Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues.
- Female patients of child bearing potential must have a negative pregnancy test at baseline.
- Patients for whom written informed consent to participate in the study has been obtained.
Exclusion criteria
- Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization
- Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C > 8%
- Patients with symptomatic cholelithiasis
- Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00690430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.