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NCT01112293 · STUDY IN CONTEXT

Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma

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

exploratory · POSTED

Assessment of time to disease progression and overall survival

Outcome analysis presented in manuscript of results of trial based on 13 participants.

exploratory · POSTED

Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in RECIST. The response assessment is based on the presence, absence, or unequivocal progression of the lesions.

Outcome analysis presented in manuscript of results of trial based on 13 participants.

exploratory · POSTED

Evaluation of changes after treatment therapy to a number of potential blood biomarkers of TGF-β effect (serum osteopontin, serum hyaluronan, serum MMP-1, serum MMP-7, serum IL-6, plasma CCL18, plasma VEGF, and plasma PAI-1). Animal models predict acute changes in TGF-β levels in blood associated with changes in serum biomarkers.

Outcome analysis presented in manuscript of results of trial based on 13 participants.

exploratory · POSTED

Comparing antibody bands in pre-treatment versus post-treatment serum

Outcome analysis presented in manuscript of results of trial based on 13 participants.

primary · POSTED

The fraction of subjects surviving 3 months without disease progression.

Outcome analysis presented in manuscript of results of trial based on 13 participants.

secondary · POSTED

The toxicity and safety of systemic infusion of anti-TGF antibody at three-week dosing intervals. Number subjects with Grade 2 and Grade 3/4 treatment related toxicities.

Outcome analysis presented in manuscript of results of trial based on 13 participants.

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-malignant-mesothelioma-recurrent-f0c1024d
nct id: NCT01112293
trial label: Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0002
source section id
NCT01112293-om-0002
source outcome index
2
endpoint
Time to Progression and Overall Survival
endpoint definition
Assessment of time to disease progression and overall survival
time origin
18 months
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Outcome analysis presented in manuscript of results of trial based on 13 participants.
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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0003
source section id
NCT01112293-om-0003
source outcome index
3
endpoint
Response Rate Using Modified RECIST Criteria for Mesothelioma
endpoint definition
Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in RECIST. The response assessment is based on the presence, absence, or unequivocal progression of the lesions.
time origin
18 months
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Outcome analysis presented in manuscript of results of trial based on 13 participants.
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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0004
source section id
NCT01112293-om-0004
source outcome index
4
endpoint
Number of Participants With a Change of Serum Biomarkers After Therapy
endpoint definition
Evaluation of changes after treatment therapy to a number of potential blood biomarkers of TGF-β effect (serum osteopontin, serum hyaluronan, serum MMP-1, serum MMP-7, serum IL-6, plasma CCL18, plasma VEGF, and plasma PAI-1). Animal models predict acute changes in TGF-β levels in blood associated with changes in serum biomarkers.
time origin
18 months
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Outcome analysis presented in manuscript of results of trial based on 13 participants.
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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0005
source section id
NCT01112293-om-0005
source outcome index
5
endpoint
Number of Participants With Systemic Humoral Anti-tumor Immune Response After Repeated Anti-TGFβ Antibody Instillation
endpoint definition
Comparing antibody bands in pre-treatment versus post-treatment serum
time origin
18 months
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Outcome analysis presented in manuscript of results of trial based on 13 participants.
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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0000
source section id
NCT01112293-om-0000
source outcome index
0
endpoint
3-month Progression Free Survival Rate
endpoint definition
The fraction of subjects surviving 3 months without disease progression.
time origin
3 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Outcome analysis presented in manuscript of results of trial based on 13 participants.
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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0001
source section id
NCT01112293-om-0001
source outcome index
1
endpoint
Toxicity and Safety of Systemic Infusion of Anti-TGF Antibody
endpoint definition
The toxicity and safety of systemic infusion of anti-TGF antibody at three-week dosing intervals. Number subjects with Grade 2 and Grade 3/4 treatment related toxicities.
time origin
18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Outcome analysis presented in manuscript of results of trial based on 13 participants.
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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0000
arm key
OG000
arm label
Investigational Drug infusion-for Safety and Effectiveness
regimen
Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01112293-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0001
arm key
OG000
arm label
Investigational Drug infusion-for Safety and Effectiveness
regimen
Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01112293-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0002
arm key
OG000
arm label
Investigational Drug infusion-for Safety and Effectiveness
regimen
Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01112293-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0003
arm key
OG000
arm label
Investigational Drug infusion-for Safety and Effectiveness
regimen
Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01112293-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0004
arm key
OG000
arm label
Investigational Drug infusion-for Safety and Effectiveness
regimen
Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01112293-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
outcome key
om-0005
arm key
OG000
arm label
Investigational Drug infusion-for Safety and Effectiveness
regimen
Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01112293-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01112293
harm key
EG000
source section id
NCT01112293-ae
event group key
EG000
event group label
Investigational Drug infusion-for Safety and Effectiveness
serious affected
6
serious at risk
14
other affected
12
other at risk
14
frequency threshold
0
collection period
Adverse event data was collected from time of first administration of study product until 30 days of the last administration of study product, approximately 1 year and 5 months.
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