TriangleNCT00113763 · STUDY IN CONTEXT
Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
Kaplan-Meier estimates of median time from randomization to death.
Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.
Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).
Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.
Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- trial label
- Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0000
- source section id
- NCT00113763-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival Time
- endpoint definition
- Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
- time origin
- From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention-to-treat (ITT)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0001
- source section id
- NCT00113763-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Kaplan-Meier estimates of median time from randomization to death.
- time origin
- From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention-to-treat (ITT)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0002
- source section id
- NCT00113763-om-0002
- source outcome index
- 2
- endpoint
- Objective Tumor Response
- endpoint definition
- Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.
- time origin
- From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention-to-treat (ITT)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0003
- source section id
- NCT00113763-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response
- endpoint definition
- Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).
- time origin
- From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention-to-treat participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0004
- source section id
- NCT00113763-om-0004
- source outcome index
- 4
- endpoint
- Time to Response
- endpoint definition
- Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.
- time origin
- From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention-to-treat (ITT) participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0005
- source section id
- NCT00113763-om-0005
- source outcome index
- 5
- endpoint
- Time to Disease Progression
- endpoint definition
- Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)
- time origin
- From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention-to-treat
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Panitumumab Plus BSC
- regimen
- Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
- analyzed count
- 231
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0000
- arm key
- OG001
- arm label
- BSC Alone
- regimen
- Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
- analyzed count
- 232
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Panitumumab Plus BSC
- regimen
- Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
- analyzed count
- 231
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0001
- arm key
- OG001
- arm label
- BSC Alone
- regimen
- Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
- analyzed count
- 232
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Panitumumab Plus BSC
- regimen
- Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
- analyzed count
- 231
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0002
- arm key
- OG001
- arm label
- BSC Alone
- regimen
- Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
- analyzed count
- 232
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Panitumumab Plus BSC
- regimen
- Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0003
- arm key
- OG001
- arm label
- BSC Alone
- regimen
- Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Panitumumab Plus BSC
- regimen
- Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0004
- arm key
- OG001
- arm label
- BSC Alone
- regimen
- Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Panitumumab Plus BSC
- regimen
- Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
- analyzed count
- 231
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- outcome key
- om-0005
- arm key
- OG001
- arm label
- BSC Alone
- regimen
- Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
- analyzed count
- 232
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00113763-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- harm key
- EG000
- source section id
- NCT00113763-ae
- event group key
- EG000
- event group label
- Panitumumab Plus BSC
- serious affected
- 101
- serious at risk
- 229
- other affected
- 224
- other at risk
- 229
- frequency threshold
- 5
- collection period
- First dose through maximum of safety FU or 30 days after last dose
- event definition
- The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Safety Analysis set includes all randomized patients, analyzed according to the treatment they actually received. Hence, 2 patients randomized to Panitumumab Plus BSC treatment group are analyzed in the BSC Alone group for safety.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00113763
- harm key
- EG001
- source section id
- NCT00113763-ae
- event group key
- EG001
- event group label
- BSC Alone
- serious affected
- 62
- serious at risk
- 234
- other affected
- 171
- other at risk
- 234
- frequency threshold
- 5
- collection period
- First dose through maximum of safety FU or 30 days after last dose
- event definition
- The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Safety Analysis set includes all randomized patients, analyzed according to the treatment they actually received. Hence, 2 patients randomized to Panitumumab Plus BSC treatment group are analyzed in the BSC Alone group for safety.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice