A Phase 3 interventional study of Pasireotide and Octreotide in Symptomatic Refractory Resistant Carcinoid Disease, sponsored by Novartis Pharmaceuticals. Completed at 62 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-30.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
152 studies on the registry are indexed under Carcinoid Tumor; 16 are open to participants now.
This study's enrollment of 186 is above the median of 36 across 106 interventional studies indexed under Carcinoid Tumor.
Browse Carcinoid Tumor studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
Drug: Pasireotide
Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
Drug: Octreotide
Pasireotide LAR 60mg i.m. injection - patients may also receive pasireotide 600 µg s.c 3 times a day for symptom control as needed
Also known as: SOM230
Octreotide LAR 40mg i.m. depot injection - Patients may also receive octreotide 100 µg s.c. 3 times a day for symptom control as needed
Also known as: Sadostatin LAR
Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.
Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): \<4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of \<5 flushing episodes. (CBRC) \<4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of \<4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.
Time frame: Month 6
Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.
Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.
Time frame: 6 months
Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.
Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.
Time frame: 6 months
Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.
Time frame: Month 6
Objective Tumor Response Rate Assessed by Investigator
Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
Time frame: Month 6
Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria
Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.
Time frame: Month 6
Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire
Time frame: Month 6
Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression
Time frame: Month 6
Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response
Time frame: Month 6
Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements
Time frame: Month 6
186 patients were screened and 110 were randomized into the study.
| Milestone | Pasireotide LAR | Octreotide LAR | Extension: Octreotide LAR/Pasireotide LAR |
|---|---|---|---|
| Started | 53 | 57 | 0 |
| Completed | 35 | 34 | 0 |
| Not completed | 18 | 23 | 0 |
| Withdrew: Abnormal laboratory value | 0 | 1 | 0 |
| Withdrew: Adverse event | 5 | 1 | 0 |
| Withdrew: Death | 0 | 2 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 3 | 0 |
| Withdrew: Subject no longer requires study drug | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 8 | 10 | 0 |
| Withdrew: Administrative problems | 0 | 1 | 0 |
| Withdrew: Early termination | 0 | 5 | 0 |
| Milestone | Pasireotide LAR | Octreotide LAR | Extension: Octreotide LAR/Pasireotide LAR |
|---|---|---|---|
| Started | 20 | 6 | 15 |
| Completed | 2 | 1 | 2 |
| Not completed | 18 | 5 | 13 |
| Withdrew: Lack of efficacy | 3 | 1 | 4 |
| Withdrew: Abnormal lab values | 1 | 0 | 0 |
| Withdrew: Abnormal test procedure results | 1 | 0 | 0 |
| Withdrew: Administrative problems | 0 | 1 | 1 |
| Withdrew: Adverse event | 2 | 1 | 2 |
| Withdrew: Death | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 |
| Withdrew: Early termination | 10 | 1 | 3 |
Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): \<4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of \<5 flushing episodes. (CBRC) \<4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of \<4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.
| Percentage of Participants | Pasireotide LAR | Octreotide LAR |
|---|---|---|
| Diarrhea and Flushing (N=37, 39) | 13.5 (4.5 to 28.8) | 28.2 (15.0 to 44.9) |
| Diarrhea (N=2, 5) | 100 (15.8 to 100) | 20.0 (0.5 to 71.6) |
| Flushing (N=4, 1) | 50 (6.8 to 93.2) | 0.0 (0.0 to 97.5) |
| Overall (N=43, 45) | 20.9 (10.0 to 36.0) | 26.7 (14.6 to 41.9) |
Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.
| Percentage of Episodes | Pasireotide LAR | Octreotide LAR |
|---|---|---|
| Diarrhea and Flushing (N=24, 28) | -23.5 ± 24.28 | -38.4 ± 28.74 |
| Predominantly Diarrhea (D) (N=2, 4) | -44.2 ± 10.26 | -22.9 ± 31.68 |
| Overall (N=26, 32) | -25.1 ± 24.04 | -36.5 ± 29.05 |
Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.
| Percentage of Episodes | Pasireotide LAR | Octreotide LAR |
|---|---|---|
| Diarrhea and Flushing (N=24, 28) | -41.0 ± 41.06 | -52.8 ± 32.18 |
| Predominately Flushing (N=4, 1) | -48.4 ± 23.13 | 47.2 ± NA |
| Overall (N=28, 29) | -42.1 ± 38.76 | -49.4 ± 36.65 |
No measurements were reported for this outcome.
Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
| Percentage of Participants | Pasireotide LAR | Octreotide LAR |
|---|---|---|
| Objective Tumor Response Rate Assessed by Investigator | 2.0 (0.0 to 10.4) | 3.8 (0.5 to 13.2) |
Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.
| Percentage of participants | Pasireotide LAR | Octreotide LAR |
|---|---|---|
| Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria | 62.7 (48.1 to 75.9) | 46.2 (32.2 to 60.5) |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pasireotide LAR | — | 15/53 (28.3%) | 50/53 (94.3%) |
| Octreotide LAR | — | 19/57 (33.3%) | 48/57 (84.2%) |
| Extension Phase Pasireotide LAR | — | 9/20 (45%) | 19/20 (95%) |
| Extension Phase Octreotide LAR | — | 2/6 (33.3%) | 5/6 (83.3%) |
| Crossover to Pasireotide LAR | — | 7/15 (46.7%) | 12/15 (80%) |
| Event | Pasireotide LAR | Octreotide LAR | Extension Phase Pasireotide LAR | Extension Phase Octreotide LAR | Crossover to Pasireotide LAR |
|---|---|---|---|---|---|
| Hepatic failureHepatobiliary disorders | 0/53 | 2/57 | 0/20 | 1/6 | 0/15 |
| DehydrationMetabolism and nutrition disorders | 2/53 | 2/57 | 1/20 | 1/6 | 1/15 |
| HyperglycaemiaMetabolism and nutrition disorders | 4/53 | 0/57 | 0/20 | 1/6 | 0/15 |
| Renal failureRenal and urinary disorders | 0/53 | 1/57 | 0/20 | 1/6 | 0/15 |
| DiarrheaGastrointestinal disorders | 4/53 | 1/57 | 1/20 | 0/6 | 1/15 |
| Cardiac failureCardiac disorders | 0/53 | 0/57 | 0/20 | 0/6 | 1/15 |
| Abdominal painGastrointestinal disorders | 3/53 | 3/57 | 1/20 | 0/6 | 1/15 |
| IleusGastrointestinal disorders | 0/53 | 0/57 | 0/20 | 0/6 | 1/15 |
| FatigueGeneral disorders | 2/53 | 2/57 | 0/20 | 0/6 | 1/15 |
| Localised oedemaGeneral disorders | 0/53 | 0/57 | 0/20 | 0/6 | 1/15 |
| Event | Pasireotide LAR | Octreotide LAR | Extension Phase Pasireotide LAR | Extension Phase Octreotide LAR | Crossover to Pasireotide LAR |
|---|---|---|---|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 15/53 | 3/57 | 7/20 | 1/6 | 2/15 |
| FatigueGeneral disorders | 11/53 | 8/57 | 6/20 | 1/6 | 3/15 |
| Oedema peripheralGeneral disorders | 9/53 | 5/57 | 5/20 | 0/6 | 3/15 |
| DiarrhoeaGastrointestinal disorders | 12/53 | 9/57 | 4/20 | 0/6 | 2/15 |
| Abdominal painGastrointestinal disorders | 8/53 | 8/57 | 1/20 | 0/6 | 3/15 |
| HaemorrhoidsGastrointestinal disorders | 1/53 | 2/57 | 4/20 | 0/6 | 0/15 |
| NauseaGastrointestinal disorders | 10/53 | 7/57 | 4/20 | 0/6 | 3/15 |
| VomitingGastrointestinal disorders | 3/53 | 7/57 | 4/20 | 0/6 | 3/15 |
| AstheniaGeneral disorders | 5/53 | 6/57 | 4/20 | 1/6 | 1/15 |
| PyrexiaGeneral disorders | 0/53 | 2/57 | 4/20 | 1/6 | 2/15 |
| Age Continuous(Years) | Pasireotide LAR | Octreotide LAR | Total |
|---|---|---|---|
| Mean | 61.2 ± 9.21 | 62.8 ± 11.91 | 62 ± 10.67 |
| Sex: Female, Male(Participants) | Pasireotide LAR | Octreotide LAR | Total |
|---|---|---|---|
| Female | 24 | 23 | 47 |
| Male | 29 | 34 | 63 |
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Novartis Pharmaceuticals