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To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus (RAD001) 70 mg/week | Experimental |
| |
| Everolimus (RAD001) 10 mg/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus (RAD001) | Drug | Everolimus was supplied in 5 mg tablets in blister packs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response). | Imaging every 8 weeks |
| The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Best Over Response (BOR): Complete Response (CR, No lesions), Partial Response (PR, 30% decrease in lesions), and Stable Disease (SD, none of the above) | Imaging every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause. | Imaging every 8 weeks |
| Overall Survival (OS) |
Not provided
Inclusion criteria:
Exclusion criteria:
Other protocol defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
Not provided
| Label | URL |
|---|---|
| Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus (RAD001) 70 mg/Week | Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. |
| FG001 | Everolimus (RAD001) 10 mg/Day | Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus (RAD001) 70 mg/Week | Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. |
| BG001 | Everolimus (RAD001) 10 mg/Day |
| 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 | Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response). | Per Protocol Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Imaging every 8 weeks |
|
Adverse events occurring up to 28 days after the discontinuation of study treatment.
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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 | Everolimus (RAD001) 70 mg/Week | Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Overall survival defined as the time from date of first study treatment to the date of death due to any cause.
| Every 3 months |
| Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr). | Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment. | From the first day of treatment until 28 days after discontinuation of study treatment |
| Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week | The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day | The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week | The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day | The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 70mg/Week | The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 10mg/Day | The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 70mg/Week | The efficacy variable that was compared in the biomarker analysis are PFS & OS within the Everolimus (RAD001) 70mg/Week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 10mg/Day | The efficacy variable that was compared in the biomarker analysis are PFS & OS within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
| Subject's no longer requires study drug |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Death |
|
| Disease progression |
|
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Everolimus (RAD001) 10 mg/Day | Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. |
|
|
| Primary | The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Best Over Response (BOR): Complete Response (CR, No lesions), Partial Response (PR, 30% decrease in lesions), and Stable Disease (SD, none of the above) | Full Analysis Set | Posted | Number | Participants | Imaging every 8 weeks |
|
|
|
| Secondary | Progression-free Survival (PFS) | Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause. | Progression- Free Survival (PFS) was analyzed in Full Analysis Set [FAS]. | Posted | Median | 95% Confidence Interval | Months | Imaging every 8 weeks |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival defined as the time from date of first study treatment to the date of death due to any cause. | Overall Survival [OS] was analyzed in Full Analysis Set [FAS]. | Posted | Median | 95% Confidence Interval | Months | Every 3 months |
|
|
|
| Secondary | Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr). | Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment. | Safety set analysis | Posted | Number | Participants | From the first day of treatment until 28 days after discontinuation of study treatment |
|
|
|
| Secondary | Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week | The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| Secondary | Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day | The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| Secondary | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week | The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Median | 95% Confidence Interval | months | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| Secondary | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day | The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Median | 95% Confidence Interval | months | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| Secondary | Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 70mg/Week | The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| Secondary | Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 10mg/Day | The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| Secondary | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 70mg/Week | The efficacy variable that was compared in the biomarker analysis are PFS & OS within the Everolimus (RAD001) 70mg/Week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Median | 95% Confidence Interval | months | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| Secondary | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 10mg/Day | The efficacy variable that was compared in the biomarker analysis are PFS & OS within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. | FAS | Posted | Median | 95% Confidence Interval | months | Screening and Day 1 of cycles 2, 3, 4 and end of treatment |
|
|
|
|
| 34 |
| 99 |
| 99 |
| 99 |
| EG001 | Everolimus (RAD001) 10 mg/Day | Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. | 22 | 100 | 98 | 100 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Malabsorption | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 10.X | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 10.X | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 10.X | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Central line infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 10.X | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.X | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Chills | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 10.X | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.X | 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 |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Disease Control (CR or PR or SD) |
|
| Objective Response (CR or PR) |
|
| Unknown |
|
| SAE regardless of relationship to study treatment |
|
| SAE with suspected relationship to study treatment |
|
| AE Grade 3-4, regardless of relationship to study |
|
| AE Grade 3-4, suspected relationship to study tr |
|
| AE leading to discontinuation |
|
| Clinically notable adverse event |
|
| Hazard Ratio, log |
| 1.001 |
| 2-Sided |
| 95 |
| 0.620 |
| 1.617 |
| Other |
| Hazard Ratio, log |
| 1.547 |
| 2-Sided |
| 95 |
| 0.884 |
| 2.708 |
| Other |
| Hazard Ratio, log |
| 1.151 |
| 2-Sided |
| 95 |
| 0.696 |
| 1.903 |
| Other |
| Hazard Ratio (HR) |
| 0.611 |
| 2-Sided |
| 95 |
| 0.314 |
| 1.191 |
| Other |