Trial · NCT01896479
A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer
NCT01896479, Phase 4, Active not recruiting, Exelixis; results first posted 2025-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer. Trials, record NCT01896479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01896479
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer
- NCT number
- NCT01896479
- Status
- Active not recruiting
- Phases
- Phase 4
- Enrollment
- 247 participants, actual
- Lead sponsor
- Exelixis
- Conditions
- Medullary Thyroid Cancer
- Interventions
- Cabozantinib (XL184) 140 mg, Cabozantinib (XL184) 60 mg, Placebo tablet, Placebo capsule
- First posted
- 2013-07-11
- Last updated
- 2026-10-20
- Results first posted
- 2025-09-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months | PFS per BIRC per RECIST 1.1 was measured from randomization until the date of first documented disease progression or date of death from any cause, whichever came first, and was assessed for up to 31 months. The prespecified primary analysis was triggered by the required number of at least 150 events occurring in the ITT population, The data cutoff date for this event-driven analysis in the ITT population was when a total of 155 events were reported. Median PFS was calculated using the Kaplan-Meier estimates. |
| Secondary | Objective Response Rate (ORR) Per BIRC Per RECIST 1.1 | Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months | ORR per BIRC per RECIST 1.1 is the percentage of ITT participants who experienced a best overall response of complete response (CR) or partial response (PR), confirmed ≥ 28 days later, CR defined as disappearance of all non-target lesions. All lymph nodes must have been non-pathological in size (\<10 mm short axis). PR defined as unequivocal progression of non-target lesions. Unequivocal progression was to trump target lesion status. It must have been representative of overall disease status change, not a single lesion increase. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months | Measured in the Intent-to-Treat (ITT) Population, which included all randomized participants. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per BIRC Per RECIST 1.1 | Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months | Measured in the ITT Population, which included all randomized participants. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Cabozantinib (XL184) 60 mg | 11 | 95% Confidence Interval 8.3 to 13.6 | months | |
| Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Cabozantinib (XL184) 140 mg | 13.9 | 95% Confidence Interval 9.0 to 16.6 | months | |
| Objective Response Rate (ORR) Per BIRC Per RECIST 1.1 | Cabozantinib (XL184) 60 mg | 33 | 95% Confidence Interval 25.09 to 42.40 | percentage of participants | |
| Objective Response Rate (ORR) Per BIRC Per RECIST 1.1 | Cabozantinib (XL184) 140 mg | 33 | 95% Confidence Interval 24.88 to 42.08 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cabozantinib (XL184) 60 mg | 123 | |
| Overall Study | STARTED | Cabozantinib (XL184) 140 mg | 124 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cabozantinib (XL184) 60 mg | 123 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cabozantinib (XL184) 140 mg | 124 | |
| Overall Study | COMPLETED | Cabozantinib (XL184) 60 mg | 123 | |
| Overall Study | COMPLETED | Cabozantinib (XL184) 140 mg | 124 | |
| Overall Study | NOT COMPLETED | Cabozantinib (XL184) 60 mg | 0 | |
| Overall Study | NOT COMPLETED | Cabozantinib (XL184) 140 mg | 0 |
Source ClinicalTrials.gov
Adverse events438
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 | Anaemia | Blood and lymphatic system disorders | Cabozantinib (XL184) 60 mg | 17 | 123 | |
| other | Anaemia | Blood and lymphatic system disorders | Cabozantinib (XL184) 140 mg | 23 | 124 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 60 mg | 13 | 123 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 140 mg | 14 | 124 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 60 mg | 7 | 123 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 140 mg | 15 | 124 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 60 mg | 12 | 123 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 140 mg | 10 | 124 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 60 mg | 9 | 123 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cabozantinib (XL184) 140 mg | 12 | 124 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cabozantinib (XL184) 60 mg | 59 | 123 |
| Total, all-cause mortality | Cabozantinib (XL184) 140 mg | 51 | 124 |
| Total, other adverse events | Cabozantinib (XL184) 60 mg | 122 | 123 |
| Total, other adverse events | Cabozantinib (XL184) 140 mg | 123 | 124 |
| Total, serious adverse events | Cabozantinib (XL184) 60 mg | 55 | 123 |
| Total, serious adverse events | Cabozantinib (XL184) 140 mg | 62 | 124 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35403447 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cabozantinib (XL184) 60 mg vs Cabozantinib (XL184) 140 mg: deaths from any cause | Trial comparisons |
| Cabozantinib (XL184) 60 mg vs Cabozantinib (XL184) 140 mg: 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/NCT01896479
GET https://conductscience.org/api/trials/v1/NCT01896479/events?page=2