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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002872-17 | EudraCT Number |
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This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus
This was a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study was to test the effectiveness and safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the lung and thymus. It was expected that a total of 120 patients with 40 patients in each arm were to be enrolled into this study. Patients were seen weekly for one month and monthly thereafter. Radiological and biochemical response assessments were performed every 3 months.
Patients with disease control (stable disease or better) in the combination arm or monotherapy with pasireotide LAR and everolimus who had not experienced unacceptable toxicity were permitted to continue treatment in the extension phase of the study and were seen every 3 months. Patients could remain in the extension phase as long as they continued to have clinical benefit and had not fulfilled any of the study discontinuation criteria. All patients had a safety follow-up visit 56 days after last treatment dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasireotide LAR | Experimental | Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 |
|
| Everolimus | Experimental | Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 |
|
| Pasireotide LAR and Everolimus Combination | Experimental | Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide LAR | Drug | 60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free". | Baseline up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Progression-free Survival (PFS) Based on RECIST v1.1 | Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1 | Baseline, every 3 months up to 69 months |
| Kaplan-Meier Estimates of Progression-free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Aarhus | 8000 C | Denmark | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29074099 | Derived | Ferolla P, Brizzi MP, Meyer T, Mansoor W, Mazieres J, Do Cao C, Lena H, Berruti A, Damiano V, Buikhuisen W, Gronbaek H, Lombard-Bohas C, Grohe C, Minotti V, Tiseo M, De Castro J, Reed N, Gislimberti G, Singh N, Stankovic M, Oberg K, Baudin E. Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2017 Dec;18(12):1652-1664. doi: 10.1016/S1470-2045(17)30681-2. Epub 2017 Oct 23. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on
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Two patients completed the core phase of the study but they did not enter the extension phase one due to worsening in clinical conditions and one for Physician decision.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pasireotide LAR | Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 |
| FG001 | Everolimus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 7, 2016 | Feb 4, 2021 |
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| Everolimus | Drug | 10 mg tables administered orally once a day |
|
|
| Pasireotide LAR and Everolimus Combination | Drug | Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily |
|
|
Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1. |
| Baseline, every 3 months up to 69 months |
| Summary of Time to Response (Months) | Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1. | Every 3 months up to Year 1 |
| Summary of Duration of Response (Months) | Date of first objective tumor response to date of tumor progression or death due to any cause. | Every 3 months up to Year 1 |
| 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) | Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1. | Baseline up to Month 12 |
| Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels | Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline. | Baseline up to Week 52 |
| Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) | Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline. | Baseline up to Month 18 |
| Kaplan-Meier Event-free Probability Estimate Based on CgA Levels | Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels >= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. | Baseline, every 3 months up to Month 18 |
| Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment | Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline. | Baseline up Month 24 |
| Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels | Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels >= 25% compared to baseline or deaths due to any cause. | Baseline, every 3 months up to Month 24 |
| Biochemical Response Rate (BRR) for 5HIAA Levels | The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of >= 50% from baseline of 5HIAA concentrations. | Baseline up Week 52 |
| Copenhagen N |
| DK-2200 |
| Denmark |
| Novartis Investigative Site | Toulouse | Cedex 9 | 31000 | France |
| Novartis Investigative Site | Créteil | 94000 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Lyon | 69437 | France |
| Novartis Investigative Site | Rennes | 35043 | France |
| Novartis Investigative Site | Strasbourg | 67091 | France |
| Novartis Investigative Site | Villejuif | 94800 | France |
| Novartis Investigative Site | Bad Berka | 99438 | Germany |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Athens | GR | 115 27 | Greece |
| Novartis Investigative Site | Ancona | AN | 60126 | Italy |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Viagrande | CT | 95029 | Italy |
| Novartis Investigative Site | Milan | MI | 20141 | Italy |
| Novartis Investigative Site | Padova | PD | 35100 | Italy |
| Novartis Investigative Site | Perugia | PG | 06129 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Roma | RM | 00128 | Italy |
| Novartis Investigative Site | Orbassano | TO | 10043 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Granada | Andalusia | 18014 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33006 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46014 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Madrid | 28046 | Spain |
| Novartis Investigative Site | Lund | 221 85 | Sweden |
| Novartis Investigative Site | Withington | Greater Manchester | M20 4BX | United Kingdom |
| Novartis Investigative Site | Glasgow | G12 0YN | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
| FG002 | Pasireotide LAR and Everolimus Combination | Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1 |
| Entered Extension Phase |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Phase |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pasireotide LAR | Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 |
| BG001 | Everolimus | Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 |
| BG002 | Pasireotide LAR and Everolimus Combination | Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free". | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 9 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Summary of Progression-free Survival (PFS) Based on RECIST v1.1 | Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1 | Full analysis set | Posted | Median | 95% Confidence Interval | months | Baseline, every 3 months up to 69 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimates of Progression-free Survival (PFS) | Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1. | Full analysis set | Posted | Number | 95% Confidence Interval | event free probability estimates | Baseline, every 3 months up to 69 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Summary of Time to Response (Months) | Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1. | Full analysis set | Posted | Number | months | Every 3 months up to Year 1 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Summary of Duration of Response (Months) | Date of first objective tumor response to date of tumor progression or death due to any cause. | Full analysis set | Posted | Number | months | Every 3 months up to Year 1 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) | Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Month 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels | Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline. | Full analysis set participants with CgA levels outside normal range at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) | Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline. | Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline | Posted | Median | 95% Confidence Interval | months | Baseline up to Month 18 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Event-free Probability Estimate Based on CgA Levels | Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels >= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. | Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline | Posted | Number | 95% Confidence Interval | event free probability estimates | Baseline, every 3 months up to Month 18 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment | Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline. | Full analysis set | Posted | Median | 95% Confidence Interval | months | Baseline up Month 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels | Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels >= 25% compared to baseline or deaths due to any cause. | Full analysis set | Posted | Number | 95% Confidence Interval | event free probability estimates | Baseline, every 3 months up to Month 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Response Rate (BRR) for 5HIAA Levels | The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of >= 50% from baseline of 5HIAA concentrations. | Full analysis set - participants with 5HIAA levels within normal range at baseline are excluded from the table, therefore 'n' stands for the number of patients with 5-HIAA levels outside normal range at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up Week 52 |
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pasireotide LAR | Pasireotide LAR | 2 | 41 | 17 | 41 | 40 | 41 |
| EG001 | Everolimus | Everolimus | 7 | 42 | 20 | 42 | 42 | 42 |
| EG002 | Pasireotide LAR and Everolimus Combination | Pasireotide LAR and Everolimus Combination | 3 | 41 | 16 | 41 | 40 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Carcinoid crisis | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Carcinoid syndrome | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Salivary gland pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cholecystocholangitis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Haematuria traumatic | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Brain compression | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Steatorrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2020 | Feb 4, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C517782 | pasireotide |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Administration problems |
|
| Disease progression |
|
| ≥65 to 84 |
|
| Male |
|
| Black |
|
| Asian |
|
|
| Stable disease |
|
| Progression-free (PF) at Month 9 |
|
|
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