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Study evaluating SOM230 in patients with metastatic carcinoid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasireotide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide (SOM230) | Drug | Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary | Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Complete Symptom Control (Days) by Dose Class | Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied. | 15 days |
| Duration of Partial Symptom Control (Days) by Dose Class |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| H. Lee Moffitt Cancer Center and Research Institute |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Pasireotide (Any Dose) | SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pasireotide (Any Dose) | SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary | Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level. | The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. | Posted | Number | participants | 15 days |
|
Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to >900μg-≤1500μg/day and 31 patients proceeded to >1500μg -≤2400μg/day.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pasireotide 300 ≤ 900 μg | Pasireotide 300 ≤ 900 μg / day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
No formal statistical comparisons were performed for this study. Summary statistics were provided to compare the different doses administered for the primary and secondary endpoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D002276 | Carcinoid Tumor |
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
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| ID | Term |
|---|---|
| C517782 | pasireotide |
Not provided
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|
|
Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval. |
| up to 15 days |
| The Number of Patients (Participants) With Overall Tumor Response | The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively. | At least 15 days |
| The Overall Safety and Tolerability of Pasireotide | Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight. | At least 15 days |
| Tampa |
| Florida |
| 33612 |
| United States |
| Univ. Of Iowa Holden Cancer Center | Iowa City | Iowa | 52242 | United States |
| Louisiana State University Medical Center | New Orleans | Louisiana | 70112 | United States |
| New Cancer Therapy |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection. |
|
|
| Secondary | Duration of Complete Symptom Control (Days) by Dose Class | Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied. | The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= the number of patients with complete symptom control. | Posted | Mean | Standard Deviation | Days | 15 days |
|
|
|
| Secondary | Duration of Partial Symptom Control (Days) by Dose Class | Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval. | The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= then number of patients with partial sympton control | Posted | Mean | Standard Deviation | Days | up to 15 days |
|
|
|
| Secondary | The Number of Patients (Participants) With Overall Tumor Response | The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively. | The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. | Posted | Number | Participants | At least 15 days |
|
|
|
| Secondary | The Overall Safety and Tolerability of Pasireotide | Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight. | The safety population consisted of all patients who received study drug (i.e. who started the pasireotide injections) and was thus identical to the Intent to treat (ITT) population. | Posted | Number | Participants | At least 15 days |
|
|
|
| 3 |
| 45 |
| 24 |
| 45 |
| EG001 | Pasireotide > 900 ≤ 1500 μg | Pasireotide > 900 ≤ 1500 μg / day | 3 | 43 | 20 | 43 |
| EG002 | Pasireotide > 1500 ≤ 2400 μg | Pasireotide > 1500 ≤ 2400 μg / day | 10 | 31 | 21 | 31 |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Erosive duodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Hepatic artery embolism | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA | Systematic Assessment |
|
| Vitamin K deficiency | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastatic carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Steatorrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| Title | Measurements |
|---|---|
|
| Progressive disease for complete treatment success |
|
| Unknown for complete treatment success |
|
| Missing for complete treatment success |
|
| Complete response for partial treatment success |
|
| Partial response for partial treatment success |
|
| Stable disease for partial treatment success |
|
| Progressive disease for partial treatment success |
|
| Unknown for partial treatment success |
|
| Missing for partial treatment success |
|
| Complete response for treatment failure |
|
| Partial response for treatment failure |
|
| Stable disease for treatment failure |
|
| Progressive disease for treatment failure |
|
| Unknown for treatment failure |
|
| Missing for treatment failure |
|
| Title | Measurements |
|---|---|
|
| Discontinued due to Adverse Events (AEs) |
|