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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003754-61 | EudraCT Number |
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The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRI + SIM 700 mg (Part A) | Experimental | Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. |
|
| FOLFIRI + SIM 200 mg (Part B) | Experimental | Participants will receive SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. |
|
| FOLFIRI + SIM 700 mg (Part B) | Experimental | Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. |
|
| FOLFIRI + Placebo (Part B) | Experimental | Participants will receive placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simtuzumab | Biological | SIM administered via intravenous infusion over 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates. | Randomization up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates. | Randomization up to 33 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Zung Thai, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35801 | United States | ||
| Banner MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28246207 | Derived | Hecht JR, Benson AB 3rd, Vyushkov D, Yang Y, Bendell J, Verma U. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab in Combination with FOLFIRI for the Second-Line Treatment of Metastatic KRAS Mutant Colorectal Adenocarcinoma. Oncologist. 2017 Mar;22(3):243-e23. doi: 10.1634/theoncologist.2016-0479. Epub 2017 Feb 28. |
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358 participants were screened.
Participants were enrolled at study sites in the United States, Russia, and Europe. The first participant was screened on 15 December 2011. The last study visit occurred on 27 February 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | FOLFIRI + SIM 700 mg (Part A) | Participants received simtuzumab (SIM) 700 mg via intravenous infusion followed by leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI; l-leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours and irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes, followed by fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours) on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo to match SIM | Drug | Placebo to match SIM administered via intravenous infusion over 30 minutes |
|
| Leucovorin | Drug | l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours |
|
|
| Irinotecan | Drug | Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes |
|
| Fluorouracil | Drug | Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours |
|
Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR.
| Randomization up to 27 months |
| Gilbert |
| Arizona |
| United States |
| Central Hematology Oncology Medical Group, Inc. | Alhambra | California | United States |
| Comprehensive Blood and Cancer Center | Bakersfield | California | United States |
| Providence Saint Joseph Medical Center-Disney Family Cancer Center | Burbank | California | United States |
| Wilshire Oncology Medical Group, Inc. | Corona | California | United States |
| Saint Jude Heritage Healthcare | Fullerton | California | United States |
| University of California San Diego Medical Center | La Jolla | California | United States |
| Pacific Shores Medical Group | Long Beach | California | United States |
| Comprehensive Hematology Oncology Centers, Inc. | Los Angeles | California | United States |
| TORI Network (Translational Oncology Research Intl) | Los Angeles | California | United States |
| UCLA Community Oncology Practice | Los Angeles | California | United States |
| Stanford University Medical Center | Palo Alto | California | United States |
| Wilshire Oncology Medical Group, Inc. | Pomona | California | United States |
| Cancer Care Associates Medical Group | Redondo Beach | California | United States |
| Pacific Shores Medical Group | Redondo Beach | California | United States |
| Sharp Health Care | San Diego | California | United States |
| San Jose Medical Group | San Jose | California | United States |
| Central Coast Medical Oncology Corp | Santa Maria | California | United States |
| Yale University Smilow Cancer Hospital | New Haven | Connecticut | 06520 | United States |
| Georgetown University | Washington D.C. | District of Columbia | United States |
| Florida Cancer Specialists | Gainesville | Florida | United States |
| MD Anderson Cancer Center | Orlando | Florida | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | United States |
| Peachtree Hematology Oncology Consultants, PC | Atlanta | Georgia | United States |
| Suburban Hematology Oncology Associates, PC | Lawrenceville | Georgia | United States |
| Northwestern University | Chicago | Illinois | United States |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | United States |
| Hematology and Oncology Associates at BridgePoint | Tupelo | Mississippi | United States |
| Saint Joseph Oncology, Inc. | Saint Joseph | Missouri | United States |
| Montana Cancer Institute | Missoula | Montana | 59802 | United States |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States |
| New York University Clinical Cancer Center | New York | New York | 10016 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | United States |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | United States |
| Oncology Hematology Care, Inc. | Wilmington | Ohio | United States |
| Kaiser Permanente Northwest Region Oncology Hematology | Portland | Oregon | United States |
| South Carolina Oncology Associates | Columbia | South Carolina | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | United States |
| Center for Cancer and Blood Disorders, PC | Fort Worth | Texas | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | United States |
| Scott & White Memorial | Temple | Texas | 76508 | United States |
| The Center for Cancer and Blood Disorders | Weatherford | Texas | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | United States |
| Intermountain Healthcare | St. George | Utah | United States |
| Virginal Cancer Specialists, PC | Fairfax | Virginia | 22033 | United States |
| Virginia Cancer Institute | Midlothian | Virginia | United States |
| Virginia Cancer Institute | Richmond | Virginia | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | United States |
| University of Wisconsin | Madison | Wisconsin | United States |
| Centre Hospitalier Universitaire Estaing | Clermont-Ferrand | Auvergne | 63003 | France |
| Centre Eugène Marquis | Rennes | Brittany Region | 35042 | France |
| Centre Georges François Leclerc | Dijon | France |
| Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique | Lille | France |
| Centre Hospitalier Régional Universitaire Hôpital Saint Eloi | Montpellier | France |
| Centre Antoine Lacassagne | Nice | France |
| Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer | Rennes | France |
| Hôpital Trousseau - Service de Gastroenterologie | Tours | France |
| Universitätsklinikums Mannheim | Mannheim | Baden-Wuerttenberg | 68167 | Germany |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Ludwig-Maximilians-Universität München Klinikum Großhadern | München | Bavaria | 81377 | Germany |
| Klinikum Region Hannover GmbH, Krankenhaus Siloah | Hanover | Lower Saxony | 30449 | Germany |
| Universitätsklinikum Rostock | Rostock | Mecklenburg-Vorpommern | 18055 | Germany |
| Medizinische Universitätsklinik Bochum | Bochum | North Rhine-Westphalia | 44892 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Krankenanstalt Mutterhaus der Borromäerinnen e.V. | Trier | Rhineland-Palatinate | 54290 | Germany |
| Universitätsklinikum Dresden | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum der Friedrich-Schiller-Universität Jena | Jena | Thuringia | 07747 | Germany |
| Städtisches Klinikum Frankfurt-Höchst | Frankfurt | Germany |
| Katholisches Marienkrankenhaus gGmbH | Hamburg | 22045 | Germany |
| University Magdeburg | Magdeburg | Germany |
| Ospedale Unico Versilia | Lido di Camaiore | Lucca | 55043 | Italy |
| Azienda Ospedaliera San Gerardo di Monza | Monza | Monza E Brianza | 20052 | Italy |
| Arcispedale Santa Maria Nuova IRCCS | Reggio Emilia | Reggio Nella Emilia | 42100 | Italy |
| Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Ospedale Niguarda Cà Granda | Milan | 20162 | Italy |
| Ospedale Civile SS Annunziata ASL 1 | Sassari | 07100 | Italy |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o. | Krakow | Lesser Poland Voivodeship | 31-826 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o. | Olsztyn | Warmian-Masurian Voivodeship | 10-513 | Poland |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy | Bydgoszcz | Poland |
| Centralny Szpital Kliniczny MSWiA | Warsaw | Poland |
| Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie | Warsaw | Poland |
| State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary" | Arkhangelsk | Russia |
| Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan | Kazan' | Russia |
| Kursk Regional Oncologic Dispensary | Kursk | Russia |
| Cancer Research Center n.a. Blokhin, Chemotherapy Dept. | Moscow | Russia |
| Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD" | Moscow | Russia |
| State Institution "Blokhin Cancer Research Centre RAMS" | Moscow | Russia |
| Nizhny Novgorod City Oncology Dispensary | Nizhny Novgorod | Russia |
| State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary" | Omsk | Russia |
| N.N.Petrov Research Institute of Oncology | Saint Petersburg | Russia |
| Centro Oncológico Regional de Galicia | A Coruña | La Coruna | 15009 | Spain |
| Hospital Nuestra Señora de Sonsoles | Ávila | 05004 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario de Girona Doctor Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro | Madrid | 28050 | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Instituto de Investigación Sanitaria | Madrid | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| FG001 | FOLFIRI + Placebo (Part B) | Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months. |
| FG002 | FOLFIRI + SIM 200 mg (Part B) | Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months. |
| FG003 | FOLFIRI + SIM 700 mg (Part B) | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants were analyzed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FOLFIRI + SIM 700 mg (Part A) | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months. |
| BG001 | FOLFIRI + Placebo (Part B) | Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months. |
| BG002 | FOLFIRI + SIM 200 mg (Part B) | Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months. |
| BG003 | FOLFIRI + SIM 700 mg (Part B) | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months. |
| BG004 | 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 | Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. | Participants in Full Analysis Set were analyzed. | Count of Participants | Participants |
| |||||||||
| Sex: Female, Male | Participants in Full Analysis Set were analyzed. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Participants in Full Analysis Set were analyzed. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Participants in Full Analysis Set were analyzed. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | 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 | Progression Free Survival (PFS) | The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates. | Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | months | Randomization up to 27 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Randomization up to 33 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization up to 27 months |
|
Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
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 | FOLFIRI + SIM 700 mg (Part A) | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months. | 4 | 11 | 11 | 11 | ||
| EG001 | FOLFIRI + Placebo (Part B) | Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months. | 27 | 80 | 76 | 80 | ||
| EG002 | FOLFIRI + SIM 200 mg (Part B) | Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months. | 24 | 85 | 80 | 85 | ||
| EG003 | FOLFIRI + SIM 700 mg (Part B) | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months. | 17 | 84 | 79 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour thrombosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lower respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oral mucosal erythema | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Axillary pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Catheter site rash | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin wrinkling | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613471 | simtuzumab |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
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| Poland |
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| Italy |
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| France |
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| Germany |
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| Spain |
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| Russia |
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| The null hypothesis was that the HR equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1. The HR (95% CI) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level ECOG performance status (0 or > 0) at randomization. | Log Rank | 0.1042 | Hazard Ratio (HR) | 1.32 | 2-Sided | 95 | 0.92 | 1.89 | Superiority |
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months. |
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| OG003 | FOLFIRI + SIM 700 mg (Part B) | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months. |
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