TriangleNCT00095628 · STUDY IN CONTEXT
SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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
Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.
Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- trial label
- SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
- 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0005
- source section id
- NCT00095628-om-0005
- source outcome index
- 5
- endpoint
- 1 Year Overall Survival
- endpoint definition
- Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
- time origin
- 12 months
- analysis role
- exploratory
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0000
- source section id
- NCT00095628-om-0000
- source outcome index
- 0
- endpoint
- Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)
- endpoint definition
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion
- time origin
- Up to 18 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 20 eligible patients were analyzed
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0001
- source section id
- NCT00095628-om-0001
- source outcome index
- 1
- endpoint
- Duration of Objective Response
- endpoint definition
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion
- time origin
- Up to 18 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data were not collected because 0 participants showed a 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0002
- source section id
- NCT00095628-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Clinical and Objective Stable Disease
- endpoint definition
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.
- time origin
- Up to 18 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0003
- source section id
- NCT00095628-om-0003
- source outcome index
- 3
- endpoint
- Median Overall Survival of SB-715992
- endpoint definition
- Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
- time origin
- Up to 18 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0004
- source section id
- NCT00095628-om-0004
- source outcome index
- 4
- endpoint
- Median Time to Progression
- endpoint definition
- Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.
- time origin
- Up to 18 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Ispinesib)
- regimen
- Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00095628-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Ispinesib)
- regimen
- Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00095628-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Ispinesib)
- regimen
- Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00095628-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Ispinesib)
- regimen
- Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00095628-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Ispinesib)
- regimen
- Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00095628-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Ispinesib)
- regimen
- Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00095628-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT00095628
- harm key
- EG000
- source section id
- NCT00095628-ae
- event group key
- EG000
- event group label
- Treatment (Ispinesib)
- serious affected
- 6
- serious at risk
- 20
- other affected
- 20
- other at risk
- 20
- frequency threshold
- 5
- collection period
- Source null
- 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