Trial · NCT02867592
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
NCT02867592, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2022-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors. Trials, record NCT02867592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02867592
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
- NCT number
- NCT02867592
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adrenal Cortical Carcinoma, Alveolar Soft Part Sarcoma, Central Nervous System Neoplasm, Childhood Clear Cell Sarcoma of Soft Tissue, Clear Cell Sarcoma of Soft Tissue, Ewing Sarcoma, Hepatoblastoma, Hepatocellular Carcinoma, Osteosarcoma, Recurrent Adrenal Cortical Carcinoma, Recurrent Alveolar Soft Part Sarcoma, Recurrent Clear Cell Sarcoma of Soft Tissue, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Hepatocellular Carcinoma, Recurrent Kidney Wilms Tumor, Recurrent Malignant Solid Neoplasm, Recurrent Osteosarcoma, Recurrent Primary Malignant Central Nervous System Neoplasm, Recurrent Renal Cell Carcinoma, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Thyroid Gland Medullary Carcinoma, Refractory Adrenal Cortical Carcinoma, Refractory Alveolar Soft Part Sarcoma, Refractory Clear Cell Sarcoma of Soft Tissue, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Hepatocellular Carcinoma, Refractory Malignant Solid Neoplasm, Refractory Osteosarcoma, Refractory Primary Central Nervous System Neoplasm, Refractory Primary Malignant Central Nervous System Neoplasm, Refractory Renal Cell Carcinoma, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory Thyroid Gland Medullary Carcinoma, Refractory Wilms Tumor, Renal Cell Carcinoma, Rhabdomyosarcoma, Soft Tissue Sarcoma, Solid Neoplasm, Thyroid Gland Medullary Carcinoma, Wilms Tumor
- Interventions
- Cabozantinib, Cabozantinib S-malate, Pharmacological Study
- First posted
- 2016-08-16
- Last updated
- 2026-08-28
- Results first posted
- 2022-11-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (Non-Osteosarcoma Strata) | Up to the first 6 cycles of therapy | 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. |
| Primary | Objective Response (Osteosarcoma Stratum) | Up to the first 6 cycles of therapy. | 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. |
| Secondary | Percentage of Participants With Adverse Events | Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy) | 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 |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Cmax | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | Day 1 PK peak concentration will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Tmax | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | Day 1 PK time to peak concentration will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: AUC | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | Day 1 PK area under the curve will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Accumulation | Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22 | PK accumulation will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Half-life | Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22 | PK half-life will be summarized by the mean and the standard deviation. |
| Secondary | Time to Progression (TTP) | Up to 1 year | Percent of patients not yet progressed at 1 year as estimated by the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was also counted as an event for this analysis. |
| Secondary | Progression Free Survival (PFS) | Up to 1 year | The 1-year Progression Free Survival will be estimated using Kaplan-Meier methodology. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (Non-Osteosarcoma Strata) | Up to the first 6 cycles of therapy | 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. | Percentage of patients | NUMBER |
| PRIMARY | Objective Response (Osteosarcoma Stratum) | Up to the first 6 cycles of therapy. | All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol in the osteosarcoma stratum. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events | Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy) | All patients who met the evaluable for toxicity criteria outlined in section 9.5 of the ADVL1622 protocol. | Percentage of patients | NUMBER |
| SECONDARY | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Cmax | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Tmax | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest. | Hour | MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: AUC | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest. | hr*ng/mL | MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Accumulation | Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22 | All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest. | Ratio | MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Half-life | Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22 | All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest. | Hour | MEAN |
| SECONDARY | Time to Progression (TTP) | Up to 1 year | All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol. | Percentage of patients | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Up to 1 year | All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol. | Percentage of patients | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (Non-Osteosarcoma Strata) | Ewing's Sarcoma | 0 | 95% Confidence Interval 0.0 to 24.71 | Percentage of patients | |
| Objective Response (Non-Osteosarcoma Strata) | Rhabdomyosarcoma | 0 | 95% Confidence Interval 0.0 to 24.71 | Percentage of patients | |
| Objective Response (Non-Osteosarcoma Strata) | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 0 | 95% Confidence Interval 0.0 to 24.71 | Percentage of patients | |
| Objective Response (Non-Osteosarcoma Strata) | Wilms Tumor | 0 | 95% Confidence Interval 0.0 to 24.71 | Percentage of patients | |
| Objective Response (Non-Osteosarcoma Strata) | Rare Tumors | 13.04 | 95% Confidence Interval 2.78 to 33.59 | Percentage of patients | |
| Objective Response (Osteosarcoma Stratum) | Osteosarcoma | 35.18 | 95% Confidence Interval 20.16 to 48.27 | Percentage of patients | |
| Percentage of Participants With Adverse Events | Ewing's Sarcoma | 61.54 | 95% Confidence Interval 31.58 to 86.14 | Percentage of patients | |
| Percentage of Participants With Adverse Events | Rhabdomyosarcoma | 38.46 | 95% Confidence Interval 13.86 to 68.42 | Percentage of patients | |
| Percentage of Participants With Adverse Events | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 61.54 | 95% Confidence Interval 31.58 to 86.14 | Percentage of patients | |
| Percentage of Participants With Adverse Events | Wilms Tumor | 38.46 | 95% Confidence Interval 13.86 to 68.42 | Percentage of patients |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ewing's Sarcoma | 15 | |
| Overall Study | STARTED | Rhabdomyosarcoma | 14 | |
| Overall Study | STARTED | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 13 | |
| Overall Study | STARTED | Wilms Tumor | 13 | |
| Overall Study | STARTED | Rare Tumors | 25 | |
| Overall Study | STARTED | Osteosarcoma | 29 | |
| Overall Study | COMPLETED | Ewing's Sarcoma | 0 | |
| Overall Study | COMPLETED | Rhabdomyosarcoma | 0 | |
| Overall Study | COMPLETED | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 0 | |
| Overall Study | COMPLETED | Wilms Tumor | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events636
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Ewing's Sarcoma | 0 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Rhabdomyosarcoma | 0 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 0 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Wilms Tumor | 1 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Rare Tumors | 0 | 23 | |
| other | Abdominal pain | Gastrointestinal disorders | Osteosarcoma | 0 | 29 | |
| other | Alanine aminotransferase increased | Investigations | Ewing's Sarcoma | 0 | 13 | |
| other | Alanine aminotransferase increased | Investigations | Rhabdomyosarcoma | 1 | 13 | |
| other | Alanine aminotransferase increased | Investigations | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 2 | 13 | |
| other | Alanine aminotransferase increased | Investigations | Wilms Tumor | 0 | 13 |
1 to 10 of 636Source ClinicalTrials.gov
See all 636 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ewing's Sarcoma | 12 | 13 |
| Total, all-cause mortality | Rhabdomyosarcoma | 10 | 13 |
| Total, all-cause mortality | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 8 | 13 |
| Total, all-cause mortality | Wilms Tumor | 10 | 13 |
| Total, all-cause mortality | Rare Tumors | 18 | 23 |
| Total, all-cause mortality | Osteosarcoma | 20 | 29 |
| Total, other adverse events | Ewing's Sarcoma | 5 | 13 |
| Total, other adverse events | Rhabdomyosarcoma | 7 | 13 |
| Total, other adverse events | Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 7 | 13 |
| Total, other adverse events | Wilms Tumor | 7 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31401903 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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