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NCT01327612 · STUDY IN CONTEXT

Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.

Participants who received at least one dose of conatumumab or ganitumab.

primary · POSTED

A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * 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.

Participants who received at least one dose of conatumumab or ganitumab.

secondary · POSTED

Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.

Participants who received at least one dose of conatumumab or ganitumab.

secondary · POSTED

Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.

Participants who received at least one dose of conatumumab or ganitumab.

secondary · POSTED

Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Participants who received at least one dose of conatumumab or ganitumab.

secondary · POSTED

Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.

Participants who received at least one dose of conatumumab or ganitumab.

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id: NCT01327612
trial label: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
source section id
NCT01327612-om-0000
source outcome index
0
endpoint
Number of Participants With Adverse Events
endpoint definition
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
time origin
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of conatumumab or ganitumab.
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0001
source section id
NCT01327612-om-0001
source outcome index
1
endpoint
Number of Participants With Serious Adverse Events
endpoint definition
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * 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.
time origin
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of conatumumab or ganitumab.
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0002
source section id
NCT01327612-om-0002
source outcome index
2
endpoint
Maximum Change From Baseline in Blood Pressure
endpoint definition
Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.
time origin
Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of conatumumab or ganitumab.
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0003
source section id
NCT01327612-om-0003
source outcome index
3
endpoint
Minimum Change From Baseline in Blood Pressure
endpoint definition
Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.
time origin
Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of conatumumab or ganitumab.
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0004
source section id
NCT01327612-om-0004
source outcome index
4
endpoint
Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
endpoint definition
Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
time origin
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of conatumumab or ganitumab.
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0005
source section id
NCT01327612-om-0005
source outcome index
5
endpoint
Best Overall Response
endpoint definition
Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.
time origin
Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of conatumumab or ganitumab.
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
arm key
OG000
arm label
20050118: Ganitumab 20 mg/kg
regimen
Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
arm key
OG001
arm label
20050171: Conatumumab 0.45 mg/kg
regimen
Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
arm key
OG002
arm label
20060295: Conatumumab 3 mg/kg
regimen
Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
arm key
OG003
arm label
20060340: Conatumumab 5 mg/kg
regimen
Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
arm key
OG004
arm label
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
regimen
Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
arm key
OG005
arm label
20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
regimen
Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0000
arm key
OG006
arm label
20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
regimen
Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0001
arm key
OG000
arm label
20050118: Ganitumab 20 mg/kg
regimen
Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0001
arm key
OG001
arm label
20050171: Conatumumab 0.45 mg/kg
regimen
Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0001
arm key
OG002
arm label
20060295: Conatumumab 3 mg/kg
regimen
Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0001
arm key
OG003
arm label
20060340: Conatumumab 5 mg/kg
regimen
Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
outcome key
om-0001
arm key
OG004
arm label
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
regimen
Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01327612-om-0001#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
harm key
EG000
source section id
NCT01327612-ae
event group key
EG000
event group label
20050118: Ganitumab 20 mg/kg
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
event definition
Source null
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
harm key
EG001
source section id
NCT01327612-ae
event group key
EG001
event group label
20050171: Conatumumab 0.45 mg/kg
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
event definition
Source null
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
harm key
EG002
source section id
NCT01327612-ae
event group key
EG002
event group label
20060295: Conatumumab 3 mg/kg
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
event definition
Source null
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
harm key
EG003
source section id
NCT01327612-ae
event group key
EG003
event group label
20060340: Conatumumab 5 mg/kg
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
event definition
Source null
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
harm key
EG004
source section id
NCT01327612-ae
event group key
EG004
event group label
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
event definition
Source null
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
harm key
EG005
source section id
NCT01327612-ae
event group key
EG005
event group label
20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
event definition
Source null
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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01327612
harm key
EG006
source section id
NCT01327612-ae
event group key
EG006
event group label
20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
event definition
Source null
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