TriangleNCT01435122 · STUDY IN CONTEXT
A Study of Axitinib in Advanced Carcinoid Tumors
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. 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
Progression-free survival rate at 12 months. PFS: determined as the time from administration of the initial dose of axitinib until objective tumor progression using Response Evaluation Criteria In Solid Tumors (RECIST), or death. Progressive Disease (PD) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Post follow-up progression free survival at time of analysis.
Tumor response rate using RECIST. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Overall survival by Kaplan Meier, determined from the time of drug administration to death from any cause. The effect of an intervention is assessed by measuring the number of subjects survived or saved after that intervention over a period of time. The time starting from a defined point to the occurrence of a given event, for example death is called as survival time and the analysis of group data as survival analysis.
Time to Treatment Failure: Time from administration of the initial dose of axitinib until study discontinuation for any reason (e.g., disease progression, toxicity, death, withdrawal of consent).
Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
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-neuroendocrine-tumor
- nct id
- NCT01435122
- trial label
- A Study of Axitinib in Advanced Carcinoid Tumors
- 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.
- 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-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0000
- source section id
- NCT01435122-om-0000
- source outcome index
- 0
- endpoint
- Rate of Progression Free Survival (PFS)
- endpoint definition
- Progression-free survival rate at 12 months. PFS: determined as the time from administration of the initial dose of axitinib until objective tumor progression using Response Evaluation Criteria In Solid Tumors (RECIST), or death. Progressive Disease (PD) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- time origin
- 12 Months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All 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-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0001
- source section id
- NCT01435122-om-0001
- source outcome index
- 1
- endpoint
- Median Progression Free Survival
- endpoint definition
- Post follow-up progression free survival at time of analysis.
- time origin
- Up to 36 Months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All 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-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0002
- source section id
- NCT01435122-om-0002
- source outcome index
- 2
- endpoint
- Tumor Response Rate
- endpoint definition
- Tumor response rate using RECIST. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- time origin
- 12 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants evaluable at time of 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-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0003
- source section id
- NCT01435122-om-0003
- source outcome index
- 3
- endpoint
- 24 Month Overall Survival (OS) Rate
- endpoint definition
- Overall survival by Kaplan Meier, determined from the time of drug administration to death from any cause. The effect of an intervention is assessed by measuring the number of subjects survived or saved after that intervention over a period of time. The time starting from a defined point to the occurrence of a given event, for example death is called as survival time and the analysis of group data as survival analysis.
- time origin
- 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All 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-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0004
- source section id
- NCT01435122-om-0004
- source outcome index
- 4
- endpoint
- Time to Treatment Failure
- endpoint definition
- Time to Treatment Failure: Time from administration of the initial dose of axitinib until study discontinuation for any reason (e.g., disease progression, toxicity, death, withdrawal of consent).
- time origin
- 12 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All 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-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0005
- source section id
- NCT01435122-om-0005
- source outcome index
- 5
- endpoint
- Occurrence of Possibly Related Adverse Events (AEs)
- endpoint definition
- Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
- time origin
- 12 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All 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-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Axitinib Administration
- regimen
- The investigational drug used in this study is axitinib, and is available as tablets.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01435122-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Axitinib Administration
- regimen
- The investigational drug used in this study is axitinib, and is available as tablets.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01435122-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Axitinib Administration
- regimen
- The investigational drug used in this study is axitinib, and is available as tablets.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01435122-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Axitinib Administration
- regimen
- The investigational drug used in this study is axitinib, and is available as tablets.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01435122-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Axitinib Administration
- regimen
- The investigational drug used in this study is axitinib, and is available as tablets.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01435122-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor
- nct id
- NCT01435122
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Axitinib Administration
- regimen
- The investigational drug used in this study is axitinib, and is available as tablets.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01435122-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor
- nct id
- NCT01435122
- harm key
- EG000
- source section id
- NCT01435122-ae
- event group key
- EG000
- event group label
- Axitinib Administration
- serious affected
- 12
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 5
- collection period
- 3 years, 10 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