Trial · NCT02243605
Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma
NCT02243605, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2020-09-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma. Trials, record NCT02243605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02243605
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma
- NCT number
- NCT02243605
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Ewing Sarcoma, Metastatic Osteosarcoma, Recurrent Ewing Sarcoma, Recurrent Osteosarcoma, Stage III Osteosarcoma AJCC v7, Stage IV Osteosarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7, Unresectable Ewing Sarcoma, Unresectable Osteosarcoma
- Interventions
- Cabozantinib S-malate, Laboratory Biomarker Analysis
- First posted
- 2014-09-18
- Last updated
- 2026-08-18
- Results first posted
- 2020-09-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-progression at 6 Months - Osteosarcoma | At 6 months | Non-progression defined as complete response (CR), partial response (PR), or stable disease (SD) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1. As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions. |
| Primary | Objective Response Within 6 Months of Treatment Onset - Osteosarcoma | Within 6 months of treatment onset | Objective response defined as complete response (CR) or partial response (PR) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1. As per revised RECIST v1.1, CR is defined as disappearance of all target and non-target lesions and normalization of tumour marker level of non-target lesions. All lymph nodes must be non-pathological in size (\<10 mm short axis). As per revised RECIST v1.1, PR is defined as a at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and non-PD/not all evaluated non-target lesions, or, CR of target lesions and non-CR/non-PD/not evaluated non-target lesions. As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions. |
| Primary | Objective Response Within 6 Months of Treatment Onset - Ewing Sarcoma | Within 6 months of treatment onset | Objective response defined as complete response (CR) or partial response (PR) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1. As per revised RECIST v1.1, CR is defined as disappearance of all target and non-target lesions and normalization of tumour marker level of non-target lesions. All lymph nodes must be non-pathological in size (\<10 mm short axis). As per revised RECIST v1.1, PR is defined as a at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and non-PD/not all evaluated non-target lesions, or, CR of target lesions and non-CR/non-PD/not evaluated non-target lesions. As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions. |
| Secondary | Best Overall Response | From the start of the treatment until disease progression/recurrence. assessed up to 2 years. | Best objective response rate, defined as the rate of CR or PR confirmed ≥ 4 weeks after initial documentation, as determined by investigator review of tumor assessments using RECIST v1.1. Complete or partial responses may be claimed only if the criteria for each are met at a subsequent time point as specified in the protocol (generally 4 weeks later). The BOR is the best response recorded from the start of the study treatment until the end of treatment * 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 * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR |
| Secondary | Progression Free Survival (PFS) | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | PFS is defined as the duration of time from start of treatment to time of progression (clinical and/or radiological) or death, whichever occurs first. Radiological progression is assessed by local review of tumor assessments using RECIST v1.1 criteria : at least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Overall Survival (OS) | Time from start of treatment to the time of death, assessed up to 2 years | OS is defined as the duration of time from start of treatment to the time of death. |
| Secondary | Non-progression at 6 Months - Ewing Sarcoma | At 6 months | Non-progression defined as complete response (CR), partial response (PR), or stable disease (SD) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1. As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions. |
| Secondary | Incidence of Adverse Events | Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. | Number of patients who had at least one adverse event related to the treatment. Adverse events were assessed using CTCAE (5.0). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Non-progression at 6 Months - Osteosarcoma | At 6 months | All patients eligible and who received at least one complete or two incomplete treatment cycles. | percentage | NUMBER |
| PRIMARY | Objective Response Within 6 Months of Treatment Onset - Osteosarcoma | Within 6 months of treatment onset | All patients eligible and who received at least one complete or two incomplete treatment cycles. | percentage | NUMBER |
| PRIMARY | Objective Response Within 6 Months of Treatment Onset - Ewing Sarcoma | Within 6 months of treatment onset | All patients eligible and who received at least one complete or two incomplete treatment cycles. | percentage | NUMBER |
| SECONDARY | Best Overall Response | From the start of the treatment until disease progression/recurrence. assessed up to 2 years. | All patients eligible and who received at least one complete or two incomplete treatment cycles. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | All patients eligible and who received at least one complete or two incomplete treatment cycles. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time from start of treatment to the time of death, assessed up to 2 years | All patients eligible and who received at least one complete or two incomplete treatment cycles. | months | MEDIAN |
| SECONDARY | Non-progression at 6 Months - Ewing Sarcoma | At 6 months | All patients eligible and who received at least one complete or two incomplete treatment cycles. | percentage | NUMBER |
| SECONDARY | Incidence of Adverse Events | Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. | Adverse event are reported for all treated patients who received at least one administration of treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Non-progression at 6 Months - Osteosarcoma | Osteosarcoma | 33.3 | 95% Confidence Interval 19.6 to 49.6 | percentage | |
| Objective Response Within 6 Months of Treatment Onset - Osteosarcoma | Osteosarcoma | 11.9 | 95% Confidence Interval 4.0 to 25.6 | percentage | |
| Objective Response Within 6 Months of Treatment Onset - Ewing Sarcoma | Ewing Sarcoma | 25.6 | 95% Confidence Interval 13.0 to 42.1 | percentage | |
| Best Overall Response | Ewing Sarcoma | Partial response | 5 | Participants | |
| Best Overall Response | Osteosarcoma | Partial response | 3 | Participants | |
| Best Overall Response | Ewing Sarcoma | Stable disease | 19 | Participants | |
| Best Overall Response | Osteosarcoma | Stable disease | 21 | Participants | |
| Best Overall Response | Ewing Sarcoma | Progressive disease | 12 | Participants | |
| Best Overall Response | Osteosarcoma | Progressive disease | 15 | Participants | |
| Best Overall Response | Ewing Sarcoma | Not evaluable | 3 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 1 - Interim Analysis Population | STARTED | Ewing Sarcoma | 23 | |
| Stage 1 - Interim Analysis Population | STARTED | Osteosarcoma | 22 | |
| Stage 1 - Interim Analysis Population | COMPLETED | Ewing Sarcoma | 21 | |
| Stage 1 - Interim Analysis Population | COMPLETED | Osteosarcoma | 21 | |
| Stage 1 - Interim Analysis Population | NOT COMPLETED | Ewing Sarcoma | 2 | |
| Stage 1 - Interim Analysis Population | NOT COMPLETED | Osteosarcoma | 1 | |
| Stage 2 - Final Analysis Population | STARTED | Ewing Sarcoma | 45 | |
| Stage 2 - Final Analysis Population | STARTED | Osteosarcoma | 45 | |
| Stage 2 - Final Analysis Population | COMPLETED | Ewing Sarcoma | 39 | |
| Stage 2 - Final Analysis Population | COMPLETED | Osteosarcoma | 42 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events260
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 | Anemia | Blood and lymphatic system disorders | Osteosarcoma | 5 | 45 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Ewing Sarcoma | 6 | 45 | 7 |
| other | Sinus tachycardia | Cardiac disorders | Osteosarcoma | 3 | 45 | 3 |
| other | Sinus tachycardia | Cardiac disorders | Ewing Sarcoma | 4 | 45 | 4 |
| other | Hypothyroidism | Endocrine disorders | Osteosarcoma | 23 | 45 | 25 |
| other | Hypothyroidism | Endocrine disorders | Ewing Sarcoma | 21 | 45 | 23 |
| other | Blurred vision | Eye disorders | Osteosarcoma | 1 | 45 | 1 |
| other | Blurred vision | Eye disorders | Ewing Sarcoma | 4 | 45 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Osteosarcoma | 8 | 45 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Ewing Sarcoma | 12 | 45 | 12 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Osteosarcoma | 42 | 45 |
| Total, all-cause mortality | Ewing Sarcoma | 37 | 45 |
| Total, other adverse events | Osteosarcoma | 45 | 45 |
| Total, other adverse events | Ewing Sarcoma | 45 | 45 |
| Total, serious adverse events | Osteosarcoma | 30 | 45 |
| Total, serious adverse events | Ewing Sarcoma | 31 | 45 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Osteosarcoma vs Ewing Sarcoma: Incidence of Adverse Events | Trial comparisons |
| Osteosarcoma vs Ewing Sarcoma: deaths from any cause | Trial comparisons |
| Osteosarcoma vs Ewing Sarcoma: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02243605
GET https://conductscience.org/api/trials/v1/NCT02243605/events?page=2