Colorectal Neoplasms Clinical Trial
— VELOUROfficial title:
A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen
The main objective of the study was to evaluate the effectiveness of aflibercept (versus
placebo) in increasing the overall survival in participants with metastatic colorectal
cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have
previously failed an oxaliplatin based treatment for metastatic disease.
The secondary objectives were to compare progression-free survival, to evaluate overall
response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV)
aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.
Status | Completed |
Enrollment | 1226 |
Est. completion date | June 2012 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Participants who met the following main selection criteria were included in the study. Inclusion Criteria: - Histologically or cytologically proven adenocarcinoma of the colon or rectum - Metastatic disease that is not amenable to potentially curative treatment - One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible) - Prior treatment with bevacizumab is permitted. Exclusion Criteria: - Prior therapy with irinotecan - Eastern Cooperative Oncology Group performance status >2 The above information is not intended to contain all considerations relevant to participation in a clinical trial. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Sanofi-Aventis Investigational Site Number 032003 | Bahia Blanca | |
Argentina | Sanofi-Aventis Investigational Site Number 032006 | Buenos Aires | |
Argentina | Sanofi-Aventis Investigational Site Number 032005 | Ciudad De Buenos Aires | |
Argentina | Sanofi-Aventis Investigational Site Number 032007 | Salta | |
Australia | Sanofi-Aventis Investigational Site Number 036004 | Hornsby | |
Australia | Sanofi-Aventis Investigational Site Number 036001 | Kingswood | |
Australia | Sanofi-Aventis Investigational Site Number 036002 | Kurralta Park | |
Australia | Sanofi-Aventis Investigational Site Number 036003 | Melbourne | |
Australia | Sanofi-Aventis Investigational Site Number 036005 | Melbourne | |
Australia | Sanofi-Aventis Investigational Site Number 036007 | Nedlands | |
Australia | Sanofi-Aventis Investigational Site Number 036006 | Subiaco | |
Austria | Sanofi-Aventis Investigational Site Number 040001 | Wien | |
Belgium | Sanofi-Aventis Investigational Site Number 056006 | Bonheiden | |
Belgium | Sanofi-Aventis Investigational Site Number 056002 | Bruxelles | |
Belgium | Sanofi-Aventis Investigational Site Number 056004 | Bruxelles | |
Belgium | Sanofi-Aventis Investigational Site Number 056007 | Bruxelles | |
Belgium | Sanofi-Aventis Investigational Site Number 056001 | Gent | |
Belgium | Sanofi-Aventis Investigational Site Number 056005 | Haine-Saint-Paul | |
Belgium | Sanofi-Aventis Investigational Site Number 056003 | Leuven | |
Brazil | Sanofi-Aventis Investigational Site Number 076002 | Porto Alegre | |
Brazil | Sanofi-Aventis Investigational Site Number 076004 | Porto Alegre | |
Brazil | Sanofi-Aventis Investigational Site Number 076005 | Porto Alegre | |
Brazil | Sanofi-Aventis Investigational Site Number 076003 | Rio De Janeiro | |
Brazil | Sanofi-Aventis Investigational Site Number 076008 | Rio De Janeiro | |
Brazil | Sanofi-Aventis Investigational Site Number 076001 | Santo Andre | |
Brazil | Sanofi-Aventis Investigational Site Number 076006 | Sao Paulo | |
Brazil | Sanofi-Aventis Investigational Site Number 076007 | Sao Paulo | |
Chile | Sanofi-Aventis Investigational Site Number 152001 | Santiago | |
Chile | Sanofi-Aventis Investigational Site Number 152002 | Santiago | |
Chile | Sanofi-Aventis Investigational Site Number 152003 | Santiago | |
Chile | Sanofi-Aventis Investigational Site Number 152005 | Santiago | |
Chile | Sanofi-Aventis Investigational Site Number 152004 | Viña Del Mar | |
Czech Republic | Sanofi-Aventis Investigational Site Number 203001 | Brno | |
Czech Republic | Sanofi-Aventis Investigational Site Number 203002 | Brno | |
Czech Republic | Sanofi-Aventis Investigational Site Number 203004 | Praha 5 | |
Denmark | Sanofi-Aventis Investigational Site Number 208003 | Ålborg | |
Denmark | Sanofi-Aventis Investigational Site Number 208001 | Odense C | |
Estonia | Sanofi-Aventis Investigational Site Number 233002 | Tallinn | |
Estonia | Sanofi-Aventis Investigational Site Number 233001 | Tartu | |
France | Sanofi-Aventis Investigational Site Number 250002 | Brest | |
France | Sanofi-Aventis Investigational Site Number 250004 | Clichy Cx | |
France | Sanofi-Aventis Investigational Site Number 250005 | La Roche Sur Yon | |
France | Sanofi-Aventis Investigational Site Number 250001 | Lyon Cedex 03 | |
France | Sanofi-Aventis Investigational Site Number 250003 | Paris | |
Germany | Sanofi-Aventis Investigational Site Number 276003 | Aschaffenburg | |
Germany | Sanofi-Aventis Investigational Site Number 276002 | Essen | |
Germany | Sanofi-Aventis Investigational Site Number 276001 | Halle / Saale | |
Germany | Sanofi-Aventis Investigational Site Number 276004 | Magdeburg | |
Germany | Sanofi-Aventis Investigational Site Number 276005 | Magdeburg | |
Germany | Sanofi-Aventis Investigational Site Number 276006 | München | |
Greece | Sanofi-Aventis Investigational Site Number 300004 | Athens | |
Greece | Sanofi-Aventis Investigational Site Number 300005 | Athens | |
Greece | Sanofi-Aventis Investigational Site Number 300001 | Heraklion | |
Greece | Sanofi-Aventis Investigational Site Number 300002 | Ilion, Athens | |
Greece | Sanofi-Aventis Investigational Site Number 300003 | Patras | |
Italy | Sanofi-Aventis Investigational Site Number 380007 | Ancona | |
Italy | Sanofi-Aventis Investigational Site Number 380005 | Aviano | |
Italy | Sanofi-Aventis Investigational Site Number 380004 | Candiolo | |
Italy | Sanofi-Aventis Investigational Site Number 380003 | Genova | |
Italy | Sanofi-Aventis Investigational Site Number 380001 | Milano | |
Italy | Sanofi-Aventis Investigational Site Number 380002 | Milano | |
Italy | Sanofi-Aventis Investigational Site Number 380008 | Rozzano | |
Italy | Sanofi-Aventis Investigational Site Number 380006 | San Giovanni Rotondo | |
Korea, Republic of | Sanofi-Aventis Investigational Site Number 410001 | Goyang | |
Korea, Republic of | Sanofi-Aventis Investigational Site Number 410002 | Seoul | |
Korea, Republic of | Sanofi-Aventis Investigational Site Number 410003 | Seoul | |
Korea, Republic of | Sanofi-Aventis Investigational Site Number 410004 | Seoul | |
Korea, Republic of | Sanofi-Aventis Investigational Site Number 410005 | Seoul | |
Netherlands | Sanofi-Aventis Investigational Site Number 528004 | Amsterdam | |
Netherlands | Sanofi-Aventis Investigational Site Number 528001 | Blaricum | |
Netherlands | Sanofi-Aventis Investigational Site Number 528005 | Breda | |
Netherlands | Sanofi-Aventis Investigational Site Number 528002 | Rotterdam | |
Netherlands | Sanofi-Aventis Investigational Site Number 528003 | Sittard-Geleen | |
New Zealand | Sanofi-Aventis Investigational Site Number 554009 | Auckland | |
New Zealand | Sanofi-Aventis Investigational Site Number 554010 | Christchurch | |
Norway | Sanofi-Aventis Investigational Site Number 578002 | Bergen | |
Norway | Sanofi-Aventis Investigational Site Number 578001 | Oslo | |
Norway | Sanofi-Aventis Investigational Site Number 578003 | Stavanger | |
Poland | Sanofi-Aventis Investigational Site Number 616005 | Czestochowa | |
Poland | Sanofi-Aventis Investigational Site Number 616004 | Elblag | |
Poland | Sanofi-Aventis Investigational Site Number 616007 | Krakow | |
Poland | Sanofi-Aventis Investigational Site Number 616003 | Lodz | |
Poland | Sanofi-Aventis Investigational Site Number 616002 | Poznan | |
Poland | Sanofi-Aventis Investigational Site Number 616006 | Rybnik | |
Poland | Sanofi-Aventis Investigational Site Number 616001 | Wroclaw | |
Puerto Rico | Sanofi-Aventis Investigational Site Number 630001 | San Juan | |
Romania | Sanofi-Aventis Investigational Site Number 642004 | Alba Iulia | |
Romania | Sanofi-Aventis Investigational Site Number 642007 | Bucharest | |
Romania | Sanofi-Aventis Investigational Site Number 642001 | Bucuresti | |
Romania | Sanofi-Aventis Investigational Site Number 642002 | Bucuresti | |
Romania | Sanofi-Aventis Investigational Site Number 642003 | Cluj Napoca | |
Romania | Sanofi-Aventis Investigational Site Number 642006 | Iasi | |
Romania | Sanofi-Aventis Investigational Site Number 642005 | Suceava | |
Russian Federation | Sanofi-Aventis Investigational Site Number 643001 | Moscow | |
Russian Federation | Sanofi-Aventis Investigational Site Number 643002 | Moscow | |
Russian Federation | Sanofi-Aventis Investigational Site Number 643006 | Moscow | |
Russian Federation | Sanofi-Aventis Investigational Site Number 643003 | Saint-Petersburg | |
Russian Federation | Sanofi-Aventis Investigational Site Number 643004 | St-Petersburg | |
Russian Federation | Sanofi-Aventis Investigational Site Number 643007 | St-Petersburg | |
South Africa | Sanofi-Aventis Investigational Site Number 710004 | Cape Town | |
South Africa | Sanofi-Aventis Investigational Site Number 710005 | Durban | |
South Africa | Sanofi-Aventis Investigational Site Number 710008 | Durban | |
South Africa | Sanofi-Aventis Investigational Site Number 710001 | Parktown | |
South Africa | Sanofi-Aventis Investigational Site Number 710006 | Port Elizabeth | |
South Africa | Sanofi-Aventis Investigational Site Number 710003 | Pretoria | |
South Africa | Sanofi-Aventis Investigational Site Number 710007 | Pretoria | |
Spain | Sanofi-Aventis Investigational Site Number 724002 | Barakaldo | |
Spain | Sanofi-Aventis Investigational Site Number 724001 | Barcelona | |
Spain | Sanofi-Aventis Investigational Site Number 724005 | Barcelona | |
Spain | Sanofi-Aventis Investigational Site Number 724003 | Madrid | |
Spain | Sanofi-Aventis Investigational Site Number 724006 | Madrid | |
Spain | Sanofi-Aventis Investigational Site Number 724007 | Reus | |
Sweden | Sanofi-Aventis Investigational Site Number 752002 | Stockholm | |
Sweden | Sanofi-Aventis Investigational Site Number 752003 | Sundsvall | |
Sweden | Sanofi-Aventis Investigational Site Number 752001 | Uppsala | |
Turkey | Sanofi-Aventis Investigational Site Number 792005 | Adana | |
Turkey | Sanofi-Aventis Investigational Site Number 792001 | Ankara | |
Turkey | Sanofi-Aventis Investigational Site Number 792004 | Ankara | |
Turkey | Sanofi-Aventis Investigational Site Number 792002 | Izmir | |
Turkey | Sanofi-Aventis Investigational Site Number 792003 | Kayseri | |
Ukraine | Sanofi-Aventis Investigational Site Number 804005 | Dnipropetrovsk | |
Ukraine | Sanofi-Aventis Investigational Site Number 804004 | Donetsk | |
Ukraine | Sanofi-Aventis Investigational Site Number 804006 | Kharkiv | |
Ukraine | Sanofi-Aventis Investigational Site Number 804002 | Kharkov | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826001 | Aberdeen | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826010 | Bournemouth | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826009 | Dudley | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826004 | London | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826007 | London | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826008 | London | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826011 | London | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826002 | Manchester | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826003 | Northwood | |
United Kingdom | Sanofi-Aventis Investigational Site Number 826005 | Sutton | |
United States | Sanofi-Aventis Investigational Site Number 840036 | Albany | New York |
United States | Sanofi-Aventis Investigational Site Number 840044 | Albuquerque | New Mexico |
United States | Sanofi-Aventis Investigational Site Number 840080 | Anaheim | California |
United States | Sanofi-Aventis Investigational Site Number 840043 | Baton Rouge | Louisiana |
United States | Sanofi-Aventis Investigational Site Number 840118 | Bethlehem | Pennsylvania |
United States | Sanofi-Aventis Investigational Site Number 840119 | Birmingham | Alabama |
United States | Sanofi-Aventis Investigational Site Number 840089 | Boynton Beach | Florida |
United States | Sanofi-Aventis Investigational Site Number 840035 | Burlington | North Carolina |
United States | Sanofi-Aventis Investigational Site Number 840085 | Charleston | South Carolina |
United States | Sanofi-Aventis Investigational Site Number 840024 | Charlotte | North Carolina |
United States | Sanofi-Aventis Investigational Site Number 840026 | Charlotte | North Carolina |
United States | Sanofi-Aventis Investigational Site Number 840087 | Chicago | Illinois |
United States | Sanofi-Aventis Investigational Site Number 840098 | Cincinnati | Ohio |
United States | Sanofi-Aventis Investigational Site Number 840078 | Corpus Christi | Texas |
United States | Sanofi-Aventis Investigational Site Number 840019 | Decatur | Illinois |
United States | Sanofi-Aventis Investigational Site Number 840115 | Elk Grove Village | Illinois |
United States | Sanofi-Aventis Investigational Site Number 840076 | Fountain Valley | California |
United States | Sanofi-Aventis Investigational Site Number 840120 | Fountain Valley | California |
United States | Sanofi-Aventis Investigational Site Number 840031 | Gainesville | Florida |
United States | Sanofi-Aventis Investigational Site Number 840041 | Gainesville | Florida |
United States | Sanofi-Aventis Investigational Site Number 840005 | Goldsboro | North Carolina |
United States | Sanofi-Aventis Investigational Site Number 840073 | Greenbrae | California |
United States | Sanofi-Aventis Investigational Site Number 840101 | Hayward | California |
United States | Sanofi-Aventis Investigational Site Number 840004 | Hendersonville | North Carolina |
United States | Sanofi-Aventis Investigational Site Number 840093 | Hot Springs | Arizona |
United States | Sanofi-Aventis Investigational Site Number 840047 | Indianapolis | Indiana |
United States | Sanofi-Aventis Investigational Site Number 840072 | Indianapolis | Indiana |
United States | Sanofi-Aventis Investigational Site Number 840081 | Kansas City | Missouri |
United States | Sanofi-Aventis Investigational Site Number 840011 | Kettering | Ohio |
United States | Sanofi-Aventis Investigational Site Number 840046 | La Jolla | California |
United States | Sanofi-Aventis Investigational Site Number 840094 | Lake Success | New York |
United States | Sanofi-Aventis Investigational Site Number 840049 | Las Vegas | Nevada |
United States | Sanofi-Aventis Investigational Site Number 840116 | Loma Linda | California |
United States | Sanofi-Aventis Investigational Site Number 840048 | Long Beach | California |
United States | Sanofi-Aventis Investigational Site Number 840088 | Louisville | Kentucky |
United States | Sanofi-Aventis Investigational Site Number 840002 | Marshfield | Wisconsin |
United States | Sanofi-Aventis Investigational Site Number 840084 | Metairie | Louisiana |
United States | Sanofi-Aventis Investigational Site Number 840122 | Miami | Florida |
United States | Sanofi-Aventis Investigational Site Number 840086 | Middletown | Ohio |
United States | Sanofi-Aventis Investigational Site Number 840034 | Munster | Indiana |
United States | Sanofi-Aventis Investigational Site Number 840074 | Muscle Shoals | Alabama |
United States | Sanofi-Aventis Investigational Site Number 840010 | Naperville | Illinois |
United States | Sanofi-Aventis Investigational Site Number 840015 | New Orleans | Louisiana |
United States | Sanofi-Aventis Investigational Site Number 840014 | Newark | Delaware |
United States | Sanofi-Aventis Investigational Site Number 840201 | Oakland | California |
United States | Sanofi-Aventis Investigational Site Number 840096 | Paducah | Kentucky |
United States | Sanofi-Aventis Investigational Site Number 840082 | Pawtucket | Rhode Island |
United States | Sanofi-Aventis Investigational Site Number 840033 | Philadelphia | Pennsylvania |
United States | Sanofi-Aventis Investigational Site Number 840012 | Pittsburgh | Pennsylvania |
United States | Sanofi-Aventis Investigational Site Number 840053 | Pontiac | Michigan |
United States | Sanofi-Aventis Investigational Site Number 840039 | Portland | Oregon |
United States | Sanofi-Aventis Investigational Site Number 840113 | Quincy | Illinois |
United States | Sanofi-Aventis Investigational Site Number 840070 | Rockville | Maryland |
United States | Sanofi-Aventis Investigational Site Number 840901 | Roseville | California |
United States | Sanofi-Aventis Investigational Site Number 840042 | Sacramento | California |
United States | Sanofi-Aventis Investigational Site Number 840301 | Sacramento | California |
United States | Sanofi-Aventis Investigational Site Number 840112 | Salinas | California |
United States | Sanofi-Aventis Investigational Site Number 840029 | Salisbury | Maryland |
United States | Sanofi-Aventis Investigational Site Number 840006 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840106 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840206 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840306 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840406 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840506 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840606 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840706 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840806 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840906 | San Diego | California |
United States | Sanofi-Aventis Investigational Site Number 840401 | San Francisco | California |
United States | Sanofi-Aventis Investigational Site Number 840601 | San Jose | California |
United States | Sanofi-Aventis Investigational Site Number 840501 | Santa Clara | California |
United States | Sanofi-Aventis Investigational Site Number 840099 | Seattle | Washington |
United States | Sanofi-Aventis Investigational Site Number 840801 | South San Francisco | California |
United States | Sanofi-Aventis Investigational Site Number 840037 | Spartanburg | South Carolina |
United States | Sanofi-Aventis Investigational Site Number 840052 | St Louis | Missouri |
United States | Sanofi-Aventis Investigational Site Number 840021 | St Louis Park | Minnesota |
United States | Sanofi-Aventis Investigational Site Number 840114 | St. Louis | Missouri |
United States | Sanofi-Aventis Investigational Site Number 840071 | Stamford | Connecticut |
United States | Sanofi-Aventis Investigational Site Number 840017 | Syracuse | New York |
United States | Sanofi-Aventis Investigational Site Number 840097 | Syracuse | New York |
United States | Sanofi-Aventis Investigational Site Number 840117 | Temple | Texas |
United States | Sanofi-Aventis Investigational Site Number 840079 | The Villages | Florida |
United States | Sanofi-Aventis Investigational Site Number 840008 | Toledo | Ohio |
United States | Sanofi-Aventis Investigational Site Number 840001 | Vallejo | California |
United States | Sanofi-Aventis Investigational Site Number 840701 | Walnut Creek | California |
United States | Sanofi-Aventis Investigational Site Number 840075 | Winston-Salem | North Carolina |
United States | Sanofi-Aventis Investigational Site Number 840095 | Woonsocket | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Sanofi | NSABP Foundation Inc, Regeneron Pharmaceuticals |
United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, Estonia, France, Germany, Greece, Italy, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. |
From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years) | No |
Secondary | Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) | PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred. |
From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months) | No |
Secondary | Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria | The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0. CR reflected the disappearance of all tumor lesions (with no new tumors) PR reflected a pre-defined reduction in tumor burden Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks. |
From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months) | No |
Secondary | Number of Participants With Adverse Events (AE) | All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported. |
From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized | Yes |
Secondary | Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay | Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay. | Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo | No |
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