NCT01803282 · STUDY IN CONTEXT

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).

→

primary · POSTED

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.

Participants in the Safety Analysis Set were analyzed.

→

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-pancreatic-cancer-locally-advanced-06747430
nct id: NCT01803282
trial label: Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced 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: 2
harms Count: 12
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
source section id
NCT01803282-om-0000
source outcome index
0
endpoint
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
endpoint definition
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
time origin
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0001
source section id
NCT01803282-om-0001
source outcome index
1
endpoint
Percentage of Participants Experiencing Laboratory Abnormalities
endpoint definition
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
time origin
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants in the Safety Analysis Set were analyzed.
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG000
arm label
Part A: ADX 200 mg
regimen
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG001
arm label
Part A: ADX 600 mg
regimen
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG002
arm label
Part A: ADX 1800 mg
regimen
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG003
arm label
Part B: PAC, ADX 800 mg
regimen
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG004
arm label
Part B: LAC, ADX 1200 mg
regimen
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG005
arm label
Part B: LSC, ADX 1200 mg
regimen
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG006
arm label
Part B: EGC, ADX 800 mg
regimen
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG007
arm label
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
regimen
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG008
arm label
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
regimen
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG009
arm label
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
regimen
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG010
arm label
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
regimen
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
outcome key
om-0000
arm key
OG011
arm label
Part B: BRCA, ADX 800 mg
regimen
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01803282-om-0000#groups/OG011

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG000
source section id
NCT01803282-ae
event group key
EG000
event group label
Part A: ADX 200 mg
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG001
source section id
NCT01803282-ae
event group key
EG001
event group label
Part A: ADX 600 mg
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG002
source section id
NCT01803282-ae
event group key
EG002
event group label
Part A: ADX 1800 mg
serious affected
2
serious at risk
6
other affected
5
other at risk
6
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG003
source section id
NCT01803282-ae
event group key
EG003
event group label
Part B: PAC, ADX 800 mg
serious affected
19
serious at risk
36
other affected
36
other at risk
36
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG004
source section id
NCT01803282-ae
event group key
EG004
event group label
Part B: LAC, ADX 1200 mg
serious affected
5
serious at risk
10
other affected
9
other at risk
10
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG005
source section id
NCT01803282-ae
event group key
EG005
event group label
Part B: LSC, ADX 1200 mg
serious affected
6
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG006
source section id
NCT01803282-ae
event group key
EG006
event group label
Part B: EGC, ADX 800 mg
serious affected
19
serious at risk
40
other affected
40
other at risk
40
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG007
source section id
NCT01803282-ae
event group key
EG007
event group label
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
serious affected
17
serious at risk
45
other affected
45
other at risk
45
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG008
source section id
NCT01803282-ae
event group key
EG008
event group label
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
serious affected
3
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG009
source section id
NCT01803282-ae
event group key
EG009
event group label
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
serious affected
13
serious at risk
44
other affected
44
other at risk
44
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG010
source section id
NCT01803282-ae
event group key
EG010
event group label
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
serious affected
4
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT01803282
harm key
EG011
source section id
NCT01803282-ae
event group key
EG011
event group label
Part B: BRCA, ADX 800 mg
serious affected
5
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
event definition
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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