A Phase 2 interventional study of SOM230 in Dumping Syndrome, sponsored by Novartis Pharmaceuticals. Completed at 17 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
43 adult patients with dumping syndrome received pasireotide s.c. during the dose escalation phase (3 months dose could be increased based on the presence of hypoglycemia during OGTT). After completing Month 3, patients were switched to pasireotide LAR for 3 months (up to Month 6). The core phase of the study was completed at the end of Month 6. Patients were allowed to enter the 6 month extension phase if they experienced benefit with pasireotide LAR treatment.
20 studies on the registry are indexed under Dumping Syndrome; 3 are open to participants now.
This study's enrollment of 43 is above the median of 30 across 17 interventional studies indexed under Dumping Syndrome.
Browse Dumping Syndrome studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:.
Patients with esophageal cancer with a negative computed tomography (CT) or Magnetic resonance imaging (MRI) scan (neck, thoracic, and upper abdominal) and albumin
≥ 3.5 g/dl at baseline.
Exclusion Criteria:
Inadequate end organ function as defined by:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with dumping syndrome treated with pasireotide
Drug: SOM230
Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg
Also known as: pasireotide
Response Rate in Plasma Glucose Level
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
Time frame: at Month 3 (M3)
Response Rate in Plasma Glucose Level
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
Time frame: at Month 6 (M6), Month 12 (M12)
Response Rate in Pulse Rate
Pulse rate was defined as percentage of patients with change in pulse rate \>=10 bpm from pre-OGTT to 30 minutes post OGTT.
Time frame: at baseline, M3, M6, M12
Response Rate in Hematocrit Levels
Percentage of patients with change in hematocrit \>= 3% from pre-OGTT to 30 minutes post OGTT.
Time frame: M3, M6, M12
Insulin Levels During OGTT
Absolute insulin levels at the end of M3, M6, M12
Time frame: M3, M6, M12
Glucagon Levels During OGTT
Absolute glucagon levels at the end of Months 3, 6 \& 12
Time frame: M3, M6, M12
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
Time frame: M3, M6, M12
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
Time frame: M3, M6, M12
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: M3, M6, M12
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Absolute Dumping Severity Score (DSS) scores at end of M3, M6 \& M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early \& late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
Time frame: M3, M6, M8
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 \& 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early \& late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.
Time frame: M3, M6, M12
Patient Global Assessment at the End of Months 3, 6 and 12
Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: "Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study" .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).
Time frame: M3, M6, M12
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values
Time frame: M1 to M3
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Time frame: M1 to M3
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Time frame: M1 to M3
Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
Time frame: M4 to M6
Summary of LAR PK Parameters by Dose
Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)
Time frame: M4 to M6
Pasireotide Concentrations in LAR Phase
Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)
Time frame: M7 to M12
LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.
Time frame: M4 to M12
43 patients were enrolled as planned; 33 patients completed the core sc phase, 31 patients completed the core LAR phase. Of the 31 patients who completed core LAR phase, 27 patients entered the extension phase. Of the 27 patients who entered the extension phase, 23 patients completed the study.
| Milestone | SOM230 |
|---|---|
| Started | 43 |
| Completed sc phase | 33 |
| Completed core phase (sc + lar) | 31 |
| Entered extension phase | 27 |
| Completed core but did no enter ext.. | 4 |
| Completed | 23 |
| Not completed | 20 |
| Withdrew: Adverse event | 6 |
| Withdrew: Unsatisfactory therapeutic effect | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Completed core, did not enter ext. phase | 4 |
| Withdrew: Administrative problems | 1 |
| Withdrew: Protocol violation | 2 |
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
| percentage of participants | SOM230 - 3 Months (sc) |
|---|---|
| Response Rate in Plasma Glucose Level | 60.5 (44.41 to 75.02) |
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
| percentage of participants | SOM230- 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|
| Response Rate in Plasma Glucose Level | 36.4 (20.40 to 54.88) | 39.4 (22.91 to 57.86) |
Pulse rate was defined as percentage of patients with change in pulse rate \>=10 bpm from pre-OGTT to 30 minutes post OGTT.
| Percentage of participants | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| rate ≥ 10 bpm at baseline | 60.5 | 24.2 | 24.2 |
| rate ≥ 10 bpm at post-baseline | 18.6 | 36.4 | 27.3 |
Percentage of patients with change in hematocrit \>= 3% from pre-OGTT to 30 minutes post OGTT.
| Percentage of participants | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| hematocrit >= 3% at baseline | 27.9 | 21.2 | 21.2 |
| hematocrit >= 3% at post baseline | 16.3 | 27.3 | 24.2 |
Absolute insulin levels at the end of M3, M6, M12
| pmol/L | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| Pre-OGTT (n= 31, 29, 21) | 37.0 ± 24.55 | 34.7 ± 19.73 | 29.0 ± 14.43 |
| 30 Minutes (n=30, 29, 23) | 196.3 ± 253.10 | 499.8 ± 276.80 | 294.1 ± 177.25 |
| 60 Minutes (n= 31, 30, 22) | 367.5 ± 354.73 | 573.2 ± 428.46 | 602.1 ± 381.6 |
| 90 Minutes (n=31, 30, 22) | 309.1 ± 263.92 | 420.4 ± 544.78 | 472.0 ± 438.82 |
| 120 Minutes(n=32, 30, 22) | 183.7 ± 209.90 | 205.7 ± 514.45 | 195.1 ± 247.43 |
| 150 Minutes(n=33, 30, 22) | 103.2 ± 166.67 | 102.8 ± 228.92 | 76.0 ± 106.05 |
| 180 Minutes (n=32, 29, 22) | 58.5 ± 52.65 | 69.1 ± 154.11 | 52.0 ± 58.81 |
Absolute glucagon levels at the end of Months 3, 6 \& 12
| pmol/L | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| Pre-OGTT (n= 31, 30, 23) | 20.70 ± 6.162 | 22.6 ± 5.85 | 21.4 ± 6.82 |
| 30 Minutes (n= 33, 29, 22) | 20.64 ± 7.037 | 25.8 ± 6.57 | 23.8 ± 6.97 |
| 60 Minutes (n= 33, 28, 22) | 20.80 ± 7.330 | 23.7 ± 5.76 | 22.9 ± 7.07 |
| 90 Minutes (n= 32, 29, 22) | 20.07 ± 7.898 | 22.7 ± 5.16 | 21.5 ± 7.69 |
| 120 Minutes (n= 32, 29, 22) | 19.73 ± 7.369 | 23.1 ± 5.40 | 22.0 ± 7.31 |
| 150 Minutes (n= 32 28, 22) | 19.94 ± 7.169 | 23.7 ± 6.67 | 21.8 ± 7.27 |
| 180 Minutes (n= 32, 29, 22) | 20.16 ± 7.097 | 22.7 ± 5.45 | 22.3 ± 6.58 |
Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
| pmol/L | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| Pre-OGTT (n=31, 29, 23) | 3.021 ± 2.1936 | 2.1 ± 1.37 | 1.6 ± 1.26 |
| 30 Minutes(n=32, 29, 22) | 12.811 ± 6.6194 | 21.0 ± 18.01 | 17.4 ± 17.64 |
| 60 Minutes (n= 32, 30, 22) | 11.208 ± 11.1218 | 14.6 ± 18.44 | 12.6 ± 8.76 |
| 90 Minutes (n=31, 29, 22) | 6.986 ± 4.9729 | 8.2 ± 4.96 | 7.2 ± 3.71 |
| 120 Minutes (n=31, 29, 22) | 5.003 ± 4.1183 | 5.2 ± 3.94 | 5.0 ± 2.98 |
| 150 Minutes(n=31, 29, 22) | 3.565 ± 2.3879 | 4.2 ± 4.20 | 3.7 ± 2.46 |
| 180 Minutes (n=31, 29, 22) | 2.974 ± 1.9902 | 3.3 ± 3.49 | 3.2 ± 2.44 |
Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
| pmol/L | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| Pre-OGTT (n=31, 29, 23) | 2.608 ± 1.7441 | 1.5 ± 1.00 | 1.7 ± 1.51 |
| 30 Minutes (n=32, 29, 22) | 15.704 ± 10.6395 | 30.3 ± 19.73 | 24.8 ± 18.88 |
| 60 Minutes (n= 32, 30, 22) | 9.471 ± 6.1861 | 14.3 ± 13.37 | 11.6 ± 9.05 |
| 90 Minutes(n=31, 29, 22) | 4.141 ± 2.8978 | 6.5 ± 7.32 | 5.2 ± 5.18 |
| 120 Minutes (n=31, 29, 22) | 2.089 ± 1.4681 | 2.4 ± 1.73 | 3.0 ± 2.81 |
| 150 Minutes (n=30, 29, 22) | 1.376 ± 1.2049 | 2.1 ± 3.22 | 1.9 ± 1.44 |
| 180 Minutes (n=31, 29, 22) | 1.260 ± 1.2218 | 3.8 ± 12.77 | 2.5 ± 3.72 |
Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
| scores on a scale | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| Physical Component Summary (n=35, 29, 23) | 44.801 ± 8.3378 | 45.306 ± 9.5622 | 46.505 ± 8.5105 |
| Mental Component Summary (n=35, 29, 23) | 44.093 ± 12.2144 | 44.838 ± 11.6573 | 47.021 ± 11.5053 |
Absolute Dumping Severity Score (DSS) scores at end of M3, M6 \& M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early \& late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
| scores on a scale | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 8 Months (Ext) |
|---|---|---|---|
| Early symptoms (n=20, 9, 2) | 7.1 ± 6.38 | 6.8 ± 6.46 | 9.0 ± 8.49 |
| Late symptoms (n=20, 9, 2) | 6.7 ± 5.42 | 6.4 ± 5.27 | 6.0 ± 4.24 |
| Overall score (n=20, 9, 2) | 13.7 ± 11.11 | 13.2 ± 10.65 | 15.0 ± 12.73 |
Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 \& 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early \& late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.
| scores on a scale | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| Early symptoms (n=15, 20, 23) | 9.6 ± 10.27 | 9.2 ± 10.05 | 10.7 ± 10.94 |
| Late symptoms (n=15, 20, 23) | 4.9 ± 5.37 | 5.6 ± 6.57 | 5.7 ± 5.93 |
| Overall score (n=15, 20, 23) | 14.5 ± 15.26 | 14.8 ± 14.65 | 16.3 ± 16.23 |
Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: "Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study" .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).
| scores on a scale | SOM230 - 3 Months (sc) | SOM230 - 6 Months (LAR) | SOM230 - 12 Months (Ext) |
|---|---|---|---|
| Patient Global Assessment at the End of Months 3, 6 and 12 | 5.1 ± 1.19 | 5.1 ± 1.27 | 5.9 ± 0.95 |
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values
| ng/mL | SOM sc 50 ug t.i.d. | SOM sc 100 ug t.i.d. | SOM sc 150 ug t.i.d. | SOM sc 200 ug t.i.d. |
|---|---|---|---|---|
| Cmax, ss (n=35, 28, 18, 10) | 1.49 ± 0.613 | 3.31 ± 1.78 | 4.56 ± 2.22 | 5.62 ± 3.18 |
| Ctrough, ss (n=37, 30, 22, 12) | 0.574 ± 0.436 | 1.11 ± 0.909 | 1.5 ± 0.798 | 2.03 ± 1.54 |
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
| hr*ng/mL | SOM sc 50 ug t.i.d. | SOM sc 100 ug t.i.d. | SOM sc 150 ug t.i.d. | SOM sc 200 ug t.i.d. |
|---|---|---|---|---|
| Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection | 3.04 ± 1.13 | 6.53 ± 3.45 | 8.84 ± 3.89 | 11.5 ± 6.23 |
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
| hr | SOM sc 50 ug t.i.d. | SOM sc 100 ug t.i.d. | SOM sc 150 ug t.i.d. | SOM sc 200 ug t.i.d. |
|---|---|---|---|---|
| Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection | 0.583 ± NA | 0.6 ± NA | 0.583 ± NA | 0.633 ± NA |
| hr*ng/mL | SOM LAR 10mg | SOM LAR 20mg |
|---|---|---|
| AUC0-3h,d21, 2nd injection (n = 12, 14) | 6.92 ± 4.12 | 14.9 ± 6.71 |
| AUC0-3h,d28, 3rd_injection (n = 9, 16) | 5.97 ± 2.41 | 9.3 ± 4.11 |
Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)
| ng/mL | SOM LAR 10mg | SOM LAR 20mg |
|---|---|---|
| Cmax, p2, 2nd_inj (n = 10, 13) | 3.2 ± 1.55 | 6.2 ± 2.6 |
| Ctrough (n= 14, 19) | 2.29 ± 1.05 | 3.33 ± 1.34 |
Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)
| ng/mL | SOM LAR 10mg | SOM LAR 20mg | SOM LAR 30mg | SOM LAR 40mg | SOM LAR 60mg |
|---|---|---|---|---|---|
| M7 - 0hr (pre-dose) (n = 4, 11, 11, 0, 0) | 2.25 ± 1.56 | 4.3 ± 2.19 | 7.76 ± 4.31 | NA ± NA | NA ± NA |
| M8 - 0hr (pre-dose) (n = 5, 7, 11, 0, 0) | 2.91 ± 2.42 | 3.77 ± 1.57 | 6.5 ± 2.91 | NA ± NA | NA ± NA |
| M9 - 0hr (pre-dose) (n = 5, 6, 9, 6, 0) | 2.97 ± 1.68 | 4.01 ± 2.27 | 6.38 ± 3.15 | 7.53 ± 4.45 | NA ± NA |
| M10 - 0hr (pre-dose) (n = 5, 6, 8, 5, 0) | 3.53 ± 1.75 | 5.48 ± 3.62 | 8.38 ± 2.81 | 11.8 ± 8.26 | NA ± NA |
| M11 - 0hr (pre-dose) (n = 5, 4, 8, 4, 3) | 3.45 ± 1.98 | 3.48 ± 0.772 | 7.99 ± 3.54 | 6.53 ± 1.83 | 17.9 ± 7.15 |
| M12 - 0hr (pre-dose) (n = 5, 3, 8, 4, 3) | 3.27 ± 2.02 | 4.63 ± 1.04 | 10.3 ± 6.05 | 6.55 ± 2.05 | 18.1 ± 13.8 |
In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.
| ng/mL | SOM LAR 10mg | SOM LAR 20mg | SOM LAR 30mg | SOM LAR 40mg |
|---|---|---|---|---|
| LAR PK Parameter: Ctrough - at Steady State (ss) by Dose | 3.34 ± 1.52 | 3.76 ± 1.48 | 8.19 ± 3.22 | 4.63 ± NA |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| s.c. Phase | — | 6/43 (14%) | 31/43 (72.1%) |
| LAR Phase | — | 10/33 (30.3%) | 25/33 (75.8%) |
| Event | s.c. Phase | LAR Phase |
|---|---|---|
| Abdominal adhesionsGastrointestinal disorders | 0/43 | 2/33 |
| Small intestinal obstructionGastrointestinal disorders | 2/43 | 0/33 |
| HypoglycaemiaMetabolism and nutrition disorders | 2/43 | 1/33 |
| Haemorrhagic anaemiaBlood and lymphatic system disorders | 0/43 | 1/33 |
| Abdominal painGastrointestinal disorders | 1/43 | 1/33 |
| Abdominal pain upperGastrointestinal disorders | 0/43 | 1/33 |
| DysphagiaGastrointestinal disorders | 0/43 | 1/33 |
| AstheniaGeneral disorders | 0/43 | 1/33 |
| Subdiaphragmatic abscessInfections and infestations | 0/43 | 1/33 |
| MalnutritionMetabolism and nutrition disorders | 0/43 | 1/33 |
| Event | s.c. Phase | LAR Phase |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 5/43 | 9/33 |
| HeadacheNervous system disorders | 10/43 | 9/33 |
| DiarrhoeaGastrointestinal disorders | 9/43 | 8/33 |
| FatigueGeneral disorders | 3/43 | 8/33 |
| Abdominal painGastrointestinal disorders | 7/43 | 7/33 |
| NauseaGastrointestinal disorders | 6/43 | 6/33 |
| NasopharyngitisInfections and infestations | 3/43 | 6/33 |
| CholelithiasisHepatobiliary disorders | 0/43 | 5/33 |
| Iron deficiencyMetabolism and nutrition disorders | 2/43 | 5/33 |
| AstheniaGeneral disorders | 5/43 | 4/33 |
The overall study full analysis set (FAS) consisted of all patients who were enrolled in the study (whether treated or not).
| Age, Continuous(Years) | SOM230 |
|---|---|
| Mean | 45.9 ± 9.99 |
| Sex: Female, Male(Participants) | SOM230 |
|---|---|
| Female | 38 |
| Male | 5 |
Ran from Jan 2013 to primary completion in Aug 2015, 30 months.
Results were first posted in May 2017, 1 year 9 months after primary completion.
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Studies of the drug tested here: Pasireotide