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Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Best Supportive Care (BSC)
Panitumumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Best Supportive Care, Panitumumab, Chemorefractory, Wild-type KRAS, Overall Survival, Phase 3

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of metastatic colorectal cancer (CRC)
  • Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.

  • Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.

    • Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
  • Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
  • Man or woman at least 18 years of age
  • Adequate hematologic, renal, hepatic and metabolic function
  • Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
  • Subject or subject's legally acceptable representative has provided informed consent.
  • Other protocol-specified criteria may apply

Exclusion Criteria:

  • Symptomatic brain metastases requiring treatment
  • History of another primary cancer within 5 years of randomization
  • Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)
  • Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization
  • Radiotherapy within 14 days before randomization.
  • Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval > 450 milliseconds at screening
  • Other protocol-specified criteria may apply

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Panitumumab + BSC

BSC Alone

Arm Description

Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus BSC until disease progression, withdrawal of consent, death, or intolerance of study drug.

Participants received best supportive care until disease progression, withdrawal of consent, or death.

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.

Secondary Outcome Measures

Progression-free Survival
Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Overall Survival in Participants With Wild-type RAS
A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
Progression Free Survival (PFS) in Participants With Wild-type RAS
PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Objective Response Rate
Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.
Objective Response Rate in Participants With Wild-type RAS
Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.
Number of Participants With Adverse Events (AEs)
The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.
Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).

Full Information

First Posted
March 31, 2011
Last Updated
February 7, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01412957
Brief Title
Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer
Official Title
A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Best Supportive Care, Panitumumab, Chemorefractory, Wild-type KRAS, Overall Survival, Phase 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panitumumab + BSC
Arm Type
Experimental
Arm Description
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus BSC until disease progression, withdrawal of consent, death, or intolerance of study drug.
Arm Title
BSC Alone
Arm Type
Other
Arm Description
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Intervention Type
Other
Intervention Name(s)
Best Supportive Care (BSC)
Intervention Description
BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated.
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Other Intervention Name(s)
Vectibix
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
Time Frame
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Time Frame
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Title
Overall Survival in Participants With Wild-type RAS
Description
A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
Time Frame
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Title
Progression Free Survival (PFS) in Participants With Wild-type RAS
Description
PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Time Frame
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Title
Objective Response Rate
Description
Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.
Time Frame
Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Title
Objective Response Rate in Participants With Wild-type RAS
Description
Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.
Time Frame
Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Title
Number of Participants With Adverse Events (AEs)
Description
The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.
Time Frame
From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.
Title
Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval
Description
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).
Time Frame
Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of metastatic colorectal cancer (CRC) Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination. Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC Man or woman at least 18 years of age Adequate hematologic, renal, hepatic and metabolic function Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only) Subject or subject's legally acceptable representative has provided informed consent. Other protocol-specified criteria may apply Exclusion Criteria: Symptomatic brain metastases requiring treatment History of another primary cancer within 5 years of randomization Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib) Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization Radiotherapy within 14 days before randomization. Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval > 450 milliseconds at screening Other protocol-specified criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80420-090
Country
Brazil
Facility Name
Research Site
City
Natal
State/Province
Rio Grande do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Research Site
City
Ijui
State/Province
Rio Grande do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Research Site
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Research Site
City
Temuco
State/Province
Cautín
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Research Site
City
Vina del Mar
State/Province
Valparaíso
ZIP/Postal Code
2520612
Country
Chile
Facility Name
Research Site
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Research Site
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Research Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Research Site
City
Xi An
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Research Site
City
Xi An
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Research Site
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Research Site
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
Research Site
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Research Site
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Research Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11522
Country
Greece
Facility Name
Research Site
City
Chania
ZIP/Postal Code
73300
Country
Greece
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 024
Country
India
Facility Name
Research Site
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530 002
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Research Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682 304
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Research Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 004
Country
India
Facility Name
Research Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 005
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Research Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 018
Country
India
Facility Name
Research Site
City
Goyang-si, Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Research Site
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Research Site
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Facility Name
Research Site
City
Nilai
State/Province
Negri Sembilan
ZIP/Postal Code
71800
Country
Malaysia
Facility Name
Research Site
City
Georgetown
State/Province
Pinang
ZIP/Postal Code
10400
Country
Malaysia
Facility Name
Research Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Research Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Research Site
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Research Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Research Site
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Research Site
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Research Site
City
Davao City
State/Province
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Research Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Research Site
City
Pasay City
ZIP/Postal Code
1300
Country
Philippines
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
022338
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Research Site
City
Lasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Research Site
City
Ploiesti
ZIP/Postal Code
100337
Country
Romania
Facility Name
Research Site
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300167
Country
Romania
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Research Site
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27736842
Citation
Kim TW, Elme A, Kusic Z, Park JO, Udrea AA, Kim SY, Ahn JB, Valencia RV, Krishnan S, Bilic A, Manojlovic N, Dong J, Guan X, Lofton-Day C, Jung AS, Vrdoljak E. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer. 2016 Nov 8;115(10):1206-1214. doi: 10.1038/bjc.2016.309. Epub 2016 Oct 13.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

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