TriangleNCT01160458 · STUDY IN CONTEXT
Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
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 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
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Duration of Overall Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
Overall survival is the time interval from the start of treatment to the date of death.
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-peritoneal-neoplasm
- nct id
- NCT01160458
- trial label
- Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
- 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
- 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
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0000
- source section id
- NCT01160458-om-0000
- source outcome index
- 0
- endpoint
- Clinical Response Rate (PR+CR)
- endpoint definition
- Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
- time origin
- 36 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0001
- source section id
- NCT01160458-om-0001
- source outcome index
- 1
- endpoint
- Safety of IMC-A12 in Patients With Mesothelioma
- endpoint definition
- Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
- time origin
- Date treatment consent signed to date off study, approximately 36 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0002
- source section id
- NCT01160458-om-0002
- source outcome index
- 2
- endpoint
- Duration of Overall Response
- endpoint definition
- Duration of Overall Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
- time origin
- 36 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No participants had a complete response or partial response.
- 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-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0003
- source section id
- NCT01160458-om-0003
- source outcome index
- 3
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
- time origin
- To study completion, an average of 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant withdrew from the study and was excluded from the analysis.
- 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-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0004
- source section id
- NCT01160458-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival is the time interval from the start of treatment to the date of death.
- time origin
- To study completion, an average of 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant withdrew from the study and was excluded from the analysis.
- 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-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0000
- arm key
- OG000
- arm label
- IMC-A12 Monotherapy in Patients
- regimen
- 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01160458-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0001
- arm key
- OG000
- arm label
- IMC-A12 Monotherapy in Patients
- regimen
- 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01160458-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0002
- arm key
- OG000
- arm label
- IMC-A12 Monotherapy in Patients
- regimen
- 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01160458-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0003
- arm key
- OG000
- arm label
- IMC-A12 Monotherapy in Patients
- regimen
- 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01160458-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT01160458
- outcome key
- om-0004
- arm key
- OG000
- arm label
- IMC-A12 Monotherapy in Patients
- regimen
- 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01160458-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT01160458
- harm key
- EG000
- source section id
- NCT01160458-ae
- event group key
- EG000
- event group label
- IMC-A12 Monotherapy in Patients
- serious affected
- 19
- serious at risk
- 20
- other affected
- 20
- other at risk
- 20
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 36 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