TriangleNCT02867592 · STUDY IN CONTEXT
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare 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. 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
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders (Overall Best Response of Partial Response or Complete Response), and confidence intervals will be constructed accounting for the two-stage design.
Will be assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 and Disease Control (see section 9.3.2 of the ADVL1622 Protocol). Response + Disease Control rate will be calculated as the percent of evaluable patients who are responders or who met the definition of disease control, and confidence intervals will be constructed accounting for the two-stage design.
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy
Day 1 PK peak concentration will be summarized by the mean and the standard deviation.
Day 1 PK time to peak concentration will be summarized by the mean and the standard deviation.
Day 1 PK area under the curve will be summarized by the mean and the standard deviation.
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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- trial label
- Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare 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. 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
- 6
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0000
- source section id
- NCT02867592-om-0000
- source outcome index
- 0
- endpoint
- Objective Response (Non-Osteosarcoma Strata)
- endpoint definition
- Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders (Overall Best Response of Partial Response or Complete Response), and confidence intervals will be constructed accounting for the two-stage design.
- time origin
- Up to the first 6 cycles of therapy
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol in non-osteosarcoma strata which were either statistical strata (Ewing's Sarcoma, Rhabdomyosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, and Rare Tumors) or accrued enough patients to be analyzed (Wilms Tumor). Data is limited for Rare tumors due to low accrual.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0001
- source section id
- NCT02867592-om-0001
- source outcome index
- 1
- endpoint
- Objective Response (Osteosarcoma Stratum)
- endpoint definition
- Will be assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 and Disease Control (see section 9.3.2 of the ADVL1622 Protocol). Response + Disease Control rate will be calculated as the percent of evaluable patients who are responders or who met the definition of disease control, and confidence intervals will be constructed accounting for the two-stage design.
- time origin
- Up to the first 6 cycles of therapy.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol in the osteosarcoma stratum.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0002
- source section id
- NCT02867592-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With Adverse Events
- endpoint definition
- Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy
- time origin
- Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who met the evaluable for toxicity criteria outlined in section 9.5 of the ADVL1622 protocol.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0003
- source section id
- NCT02867592-om-0003
- source outcome index
- 3
- endpoint
- Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Cmax
- endpoint definition
- Day 1 PK peak concentration will be summarized by the mean and the standard deviation.
- time origin
- Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0004
- source section id
- NCT02867592-om-0004
- source outcome index
- 4
- endpoint
- Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Tmax
- endpoint definition
- Day 1 PK time to peak concentration will be summarized by the mean and the standard deviation.
- time origin
- Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0005
- source section id
- NCT02867592-om-0005
- source outcome index
- 5
- endpoint
- Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: AUC
- endpoint definition
- Day 1 PK area under the curve will be summarized by the mean and the standard deviation.
- time origin
- Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Ewing's Sarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Rhabdomyosarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Non-Rhabdomyosarcoma Soft Tissue Sarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Wilms Tumor
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Rare Tumors
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Osteosarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Ewing's Sarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Rhabdomyosarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Non-Rhabdomyosarcoma Soft Tissue Sarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Wilms Tumor
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0002
- arm key
- OG004
- arm label
- Rare Tumors
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0002#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- outcome key
- om-0002
- arm key
- OG005
- arm label
- Osteosarcoma
- regimen
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02867592-om-0002#groups/OG005
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- harm key
- EG000
- source section id
- NCT02867592-ae
- event group key
- EG000
- event group label
- Ewing's Sarcoma
- serious affected
- 6
- serious at risk
- 13
- other affected
- 5
- other at risk
- 13
- frequency threshold
- 0
- collection period
- From start of treatment to 30 days after last dose, a median of 3.4 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- harm key
- EG001
- source section id
- NCT02867592-ae
- event group key
- EG001
- event group label
- Rhabdomyosarcoma
- serious affected
- 2
- serious at risk
- 13
- other affected
- 7
- other at risk
- 13
- frequency threshold
- 0
- collection period
- From start of treatment to 30 days after last dose, a median of 3.4 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- harm key
- EG002
- source section id
- NCT02867592-ae
- event group key
- EG002
- event group label
- Non-Rhabdomyosarcoma Soft Tissue Sarcoma
- serious affected
- 4
- serious at risk
- 13
- other affected
- 7
- other at risk
- 13
- frequency threshold
- 0
- collection period
- From start of treatment to 30 days after last dose, a median of 3.4 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- harm key
- EG003
- source section id
- NCT02867592-ae
- event group key
- EG003
- event group label
- Wilms Tumor
- serious affected
- 6
- serious at risk
- 13
- other affected
- 7
- other at risk
- 13
- frequency threshold
- 0
- collection period
- From start of treatment to 30 days after last dose, a median of 3.4 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- harm key
- EG004
- source section id
- NCT02867592-ae
- event group key
- EG004
- event group label
- Rare Tumors
- serious affected
- 10
- serious at risk
- 23
- other affected
- 13
- other at risk
- 23
- frequency threshold
- 0
- collection period
- From start of treatment to 30 days after last dose, a median of 3.4 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- 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-soft-tissue-sarcoma-pediatric
- nct id
- NCT02867592
- harm key
- EG005
- source section id
- NCT02867592-ae
- event group key
- EG005
- event group label
- Osteosarcoma
- serious affected
- 8
- serious at risk
- 29
- other affected
- 17
- other at risk
- 29
- frequency threshold
- 0
- collection period
- From start of treatment to 30 days after last dose, a median of 3.4 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- 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