Trial · NCT01908426
Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
NCT01908426, Phase 3, Completed, Exelixis; results first posted 2019-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib. Trials, record NCT01908426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01908426
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
- NCT number
- NCT01908426
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 707 participants, actual
- Lead sponsor
- Exelixis
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Cabozantinib tablets, Placebo tablets
- First posted
- 2013-07-25
- Last updated
- 2021-05-06
- Results first posted
- 2019-03-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 45 months | The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates. |
| Secondary | Progression-Free Survival (PFS) | Up to 45 months | Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration. |
| Secondary | Objective Response Rate (ORR) | ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 months) | 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 lesions; Overall Response (OR) = CR + PR. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 45 months | The ITT population was used and included 707 randomized subjects (470 cabozantinib, 237 placebo) in the second interim analysis with a cutoff date of 01 June 2017. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to 45 months | The prespecified primary analysis of PFS was based on the first 707 randomized subjects (470 cabozantinib, 237 placebo). | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 months) | The analysis of ORR was performed in the ITT population (all randomized: 470 cabozantinib, 237 placebo) based upon response determined by Investigator per RECIST 1.1 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Cabozantinib (XL184) | 10.2 | 95% Confidence Interval 9.1 to 12.0 | months | |
| Overall Survival (OS) | Placebo | 8.0 | 95% Confidence Interval 6.8 to 9.4 | months | |
| Progression-Free Survival (PFS) | Cabozantinib (XL184) | 5.2 | 95% Confidence Interval 4.0 to 5.5 | months | |
| Progression-Free Survival (PFS) | Placebo | 1.9 | 95% Confidence Interval 1.9 to 1.9 | months | |
| Objective Response Rate (ORR) | Cabozantinib (XL184) | 18 | Participants | ||
| Objective Response Rate (ORR) | Placebo | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cabozantinib (XL184) | 470 | |
| Overall Study | STARTED | Placebo | 237 | |
| Overall Study | COMPLETED | Cabozantinib (XL184) | 73 | |
| Overall Study | COMPLETED | Placebo | 26 | |
| Overall Study | NOT COMPLETED | Cabozantinib (XL184) | 397 | |
| Overall Study | NOT COMPLETED | Placebo | 211 |
Source ClinicalTrials.gov
Adverse events530
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 | Thrombocytopenia | Blood and lymphatic system disorders | Cabozantinib (XL184) | 51 | 467 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 1 | 237 | |
| other | Hypothyroidism | Endocrine disorders | Cabozantinib (XL184) | 38 | 467 | |
| other | Hypothyroidism | Endocrine disorders | Placebo | 1 | 237 | |
| other | Diarrhoea | Gastrointestinal disorders | Cabozantinib (XL184) | 251 | 467 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 43 | 237 | |
| other | Dyspepsia | Gastrointestinal disorders | Cabozantinib (XL184) | 47 | 467 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 7 | 237 | |
| other | Nausea | Gastrointestinal disorders | Cabozantinib (XL184) | 147 | 467 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 41 | 237 |
1 to 10 of 530Source ClinicalTrials.gov
See all 530 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cabozantinib (XL184) | 314 | 467 |
| Total, all-cause mortality | Placebo | 167 | 237 |
| Total, other adverse events | Cabozantinib (XL184) | 445 | 467 |
| Total, other adverse events | Placebo | 173 | 237 |
| Total, serious adverse events | Cabozantinib (XL184) | 232 | 467 |
| Total, serious adverse events | Placebo | 87 | 237 |
Source ClinicalTrials.gov
Papers6
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 |
|---|---|
| Cabozantinib (XL184) vs Placebo: Objective Response Rate (ORR) | Trial comparisons |
| Cabozantinib (XL184) vs Placebo: deaths from any cause | Trial comparisons |
| Cabozantinib (XL184) vs Placebo: 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/NCT01908426
GET https://conductscience.org/api/trials/v1/NCT01908426/events?page=2