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EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer (POSEIDON)

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EMD 525797 250 mg
EMD 525797 500 mg
EMD 525797 750 mg
EMD 525797 1000 mg
Cetuximab
Irinotecan
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring EMD 525797, Cetuximab, Irinotecan, metastatic colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis

  • Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease
  • Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (PD) (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing retreatment
  • At least 1 radiographically documented measurable lesion in a previously non irradiated area according to Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as greater than or equal to (>=) 2 centimeter (cm) by conventional techniques or >=1 cm by spiral computed tomography (CT) scan
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or Karnofsky performance status (KPS) >= 80 percent (%)
  • Absolute Neutrophil Count (ANC) >=1.5 x 10^9/Liter
  • Platelets >=100 x 10^9/Liter
  • Hemoglobin >=9 gram per deciliter (g/dL) (without transfusions)
  • Bilirubin less than or equal to (<=) 1.5 x upper limit normal (ULN)
  • Aspartate transaminase (AST) <=5 x ULN and alanine transaminase (ALT) <=5 x ULN
  • Serum creatinine <=1.25 x ULN and/or creatinine clearance >=50 milliliter per minute (mL/min)
  • International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits
  • Sodium and potassium within normal limits or <=10% above or below (supplementation permitted)

Exclusion Criteria:

  • Previous treatment with any inhibitor of Epidermal Growth Factor Receptor (EGFR)
  • Known brain metastasis and/or leptomeningeal disease
  • Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry; planned major surgery during the trial
  • Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed)
  • Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
  • Uncontrolled hypertension defined as systolic blood pressure >=160 millimeter of mercury (mmHg) and/or diastolic blood pressure >=100 mmHg under resting conditions
  • History of coagulation disorder associated with bleeding or recurrent thrombotic events
  • History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of trial treatment start
  • Chronic inflammatory bowel disease, or acute/chronic ileus
  • Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Safety part: EMD 525797 250 mg + Standard of Care (SoC)

Safety part: EMD 525797 500 mg + SoC

Safety part: EMD 525797 750 mg + SoC

Safety part: EMD 525797 1000 mg + SoC

Randomized part: EMD 525797 500 mg + SoC

Randomized Part: EMD 525797 1000 mg + SoC

Randomized Part: SoC

Arm Description

EMD 525797 250 mg in combination with cetuximab and irinotecan

EMD 525797 500 mg in combination with cetuximab and irinotecan

EMD 525797 750 mg in combination with cetuximab and irinotecan

EMD 525797 1000 mg in combination with cetuximab and irinotecan

EMD 525797 500 mg in combination with cetuximab and irinotecan

EMD 525797 1000 mg (or dose as defined by safety monitoring committee (SMC)] in combination with cetuximab and irinotecan.

Cetuximab and irinotecan

Outcomes

Primary Outcome Measures

Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)
DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.
Randomized Part: Progression Free Survival (PFS)
PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.

Secondary Outcome Measures

Overall Survival (OS) Time
OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.
Time to Progression (TTP)
TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.
Number of Subjects With Tumor Response
Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.
Time to Treatment Failure (TTF)
TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.

Full Information

First Posted
October 19, 2009
Last Updated
February 26, 2016
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01008475
Brief Title
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
Acronym
POSEIDON
Official Title
An Open-label, Randomized, Controlled, Multicenter, Phase I/II Trial Investigating 2 EMD 525797 Doses in Combination With Cetuximab and Irinotecan Versus Cetuximab and Irinotecan Alone, as Second-line Treatment for Subjects With K-ras Wild Type Metastatic Colorectal Cancer (mCRC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
EMD 525797, Cetuximab, Irinotecan, metastatic colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety part: EMD 525797 250 mg + Standard of Care (SoC)
Arm Type
Experimental
Arm Description
EMD 525797 250 mg in combination with cetuximab and irinotecan
Arm Title
Safety part: EMD 525797 500 mg + SoC
Arm Type
Experimental
Arm Description
EMD 525797 500 mg in combination with cetuximab and irinotecan
Arm Title
Safety part: EMD 525797 750 mg + SoC
Arm Type
Experimental
Arm Description
EMD 525797 750 mg in combination with cetuximab and irinotecan
Arm Title
Safety part: EMD 525797 1000 mg + SoC
Arm Type
Experimental
Arm Description
EMD 525797 1000 mg in combination with cetuximab and irinotecan
Arm Title
Randomized part: EMD 525797 500 mg + SoC
Arm Type
Experimental
Arm Description
EMD 525797 500 mg in combination with cetuximab and irinotecan
Arm Title
Randomized Part: EMD 525797 1000 mg + SoC
Arm Type
Experimental
Arm Description
EMD 525797 1000 mg (or dose as defined by safety monitoring committee (SMC)] in combination with cetuximab and irinotecan.
Arm Title
Randomized Part: SoC
Arm Type
Other
Arm Description
Cetuximab and irinotecan
Intervention Type
Drug
Intervention Name(s)
EMD 525797 250 mg
Intervention Description
EMD 525797 will be administered at a target dose of 250 mg as a 1-hour intravenous infusion for every 2 week until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
Intervention Type
Drug
Intervention Name(s)
EMD 525797 500 mg
Intervention Description
Safety part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . Randomized part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
EMD 525797 750 mg
Other Intervention Name(s)
Abituzumab
Intervention Description
EMD 525797 will be administered at a target dose of 750 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
Intervention Type
Drug
Intervention Name(s)
EMD 525797 1000 mg
Other Intervention Name(s)
Abituzumab
Intervention Description
Safety part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . Randomized part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Safety part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly until DLT. Randomized part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Safety part: Irinotecan will be administered at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . Randomized part: Irinotecan will be administered at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Primary Outcome Measure Information:
Title
Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)
Description
DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.
Time Frame
Time from the first dose of study drug up to 2 weeks
Title
Randomized Part: Progression Free Survival (PFS)
Description
PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.
Time Frame
Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) Time
Description
OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.
Time Frame
Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
Title
Time to Progression (TTP)
Description
TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.
Time Frame
Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
Title
Number of Subjects With Tumor Response
Description
Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.
Time Frame
Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)
Title
Time to Treatment Failure (TTF)
Description
TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.
Time Frame
Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (PD) (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing retreatment At least 1 radiographically documented measurable lesion in a previously non irradiated area according to Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as greater than or equal to (>=) 2 centimeter (cm) by conventional techniques or >=1 cm by spiral computed tomography (CT) scan Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or Karnofsky performance status (KPS) >= 80 percent (%) Absolute Neutrophil Count (ANC) >=1.5 x 10^9/Liter Platelets >=100 x 10^9/Liter Hemoglobin >=9 gram per deciliter (g/dL) (without transfusions) Bilirubin less than or equal to (<=) 1.5 x upper limit normal (ULN) Aspartate transaminase (AST) <=5 x ULN and alanine transaminase (ALT) <=5 x ULN Serum creatinine <=1.25 x ULN and/or creatinine clearance >=50 milliliter per minute (mL/min) International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits Sodium and potassium within normal limits or <=10% above or below (supplementation permitted) Exclusion Criteria: Previous treatment with any inhibitor of Epidermal Growth Factor Receptor (EGFR) Known brain metastasis and/or leptomeningeal disease Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry; planned major surgery during the trial Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed) Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia Uncontrolled hypertension defined as systolic blood pressure >=160 millimeter of mercury (mmHg) and/or diastolic blood pressure >=100 mmHg under resting conditions History of coagulation disorder associated with bleeding or recurrent thrombotic events History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of trial treatment start Chronic inflammatory bowel disease, or acute/chronic ileus Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof. Josep Tabernero
Organizational Affiliation
HU Vall d' Hebron, Servei d'oncologia. E difici General
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Edegem
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Strovolos
State/Province
Nicosia
Country
Cyprus
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Horovice
Country
Czech Republic
Facility Name
Research Site
City
Kutna Hora
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
Country
Czech Republic
Facility Name
Research Site
City
Prague
Country
Czech Republic
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Freiburg
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Heilbronn
Country
Germany
Facility Name
Research Site
City
Landshut
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Munich
Country
Germany
Facility Name
Research Site
City
Recklinghausen
Country
Germany
Facility Name
Research Site
City
Ulm
Country
Germany
Facility Name
Research Site
City
Thessaloniki
State/Province
Cyprus
Country
Greece
Facility Name
Research Site
City
Mournies Chania
Country
Greece
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Szolnok
Country
Hungary
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Ramat Gan
Country
Israel
Facility Name
Research Site
City
Rechovot
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
Country
Israel
Facility Name
Research Site
City
Elblag
Country
Poland
Facility Name
Research Site
City
Gdańsk
Country
Poland
Facility Name
Research Site
City
Gliwice
Country
Poland
Facility Name
Research Site
City
Rybnik
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Łódź
Country
Poland
Facility Name
Research
City
Arkhangelsk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Omsk
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Elche
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Mallorca
Country
Spain
Facility Name
Research Site
City
Santander
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
Country
Spain
Facility Name
Research Site
City
Terrassa
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Aberdeen
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
Facility Name
Research Site
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25319061
Citation
Elez E, Kocakova I, Hohler T, Martens UM, Bokemeyer C, Van Cutsem E, Melichar B, Smakal M, Csoszi T, Topuzov E, Orlova R, Tjulandin S, Rivera F, Straub J, Bruns R, Quaratino S, Tabernero J. Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial. Ann Oncol. 2015 Jan;26(1):132-140. doi: 10.1093/annonc/mdu474. Epub 2014 Oct 15.
Results Reference
derived

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EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer

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