Trial · NCT00699374
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
NCT00699374, Phase 3, Terminated, Pfizer; results first posted 2013-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer. Trials, record NCT00699374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00699374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
- NCT number
- NCT00699374
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,075 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- sunitinib malate, sorafenib
- First posted
- 2008-06-18
- Last updated
- 2013-01-14
- Results first posted
- 2013-01-14
- Limitations and caveats
- Study terminated early due to futility. Subsequently, EQ-5D data were not collected or analyzed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 | Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. |
| Secondary | Progression-Free Survival (PFS) | Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 | The period from randomization until disease progression or death. |
| Secondary | Time to Tumor Progression (TTP) | Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 | Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]) |
| Secondary | European Quality of Life (EQ-5D)- Health State Profile Utility Score | Day 1 of each cycle | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 | Full Analysis Population, all randomized participants where participants were classifed according to the randomized treatment arm regardless of what treatment, if any, was received. | Weeks | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 | Full Analysis Population | Weeks | MEDIAN |
| SECONDARY | Time to Tumor Progression (TTP) | Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 | Full Analysis Population | Weeks | MEDIAN |
| SECONDARY | European Quality of Life (EQ-5D)- Health State Profile Utility Score | Day 1 of each cycle | Data were not collected per Amendment 2 to the protocol removing collection for this endpoint. |
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) | Sunitinib | 34.3 | 95% Confidence Interval 31.9 to 39.9 | Weeks | |
| Overall Survival (OS) | Sorafenib | 43.9 | 95% Confidence Interval 38.1 to 48.7 | Weeks | |
| Progression-Free Survival (PFS) | Sunitinib | 15.3 | 95% Confidence Interval 12.1 to 17.7 | Weeks | |
| Progression-Free Survival (PFS) | Sorafenib | 12.6 | 95% Confidence Interval 12.1 to 17.3 | Weeks | |
| Time to Tumor Progression (TTP) | Sunitinib | 17.7 | 95% Confidence Interval 13.6 to 18.0 | Weeks | |
| Time to Tumor Progression (TTP) | Sorafenib | 15.4 | 95% Confidence Interval 12.3 to 18.1 | Weeks |
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 | Sunitinib | 530 | |
| Overall Study | STARTED | Sorafenib | 544 | |
| Overall Study | Treated | Sunitinib | 526 | |
| Overall Study | Treated | Sorafenib | 542 | |
| Overall Study | COMPLETED | Sunitinib | 0 | |
| Overall Study | COMPLETED | Sorafenib | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib | 530 | |
| Overall Study | NOT COMPLETED | Sorafenib | 544 |
Source ClinicalTrials.gov
Adverse events608
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 | Sunitinib | 79 | 526 | |
| other | Anaemia | Blood and lymphatic system disorders | Sorafenib | 47 | 542 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib | 96 | 526 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sorafenib | 37 | 542 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 119 | 526 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sorafenib | 19 | 542 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 170 | 526 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sorafenib | 69 | 542 | |
| other | Hypothyroidism | Endocrine disorders | Sunitinib | 30 | 526 | |
| other | Hypothyroidism | Endocrine disorders | Sorafenib | 7 | 542 |
1 to 10 of 608Source ClinicalTrials.gov
See all 608 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib | ||
| Total, all-cause mortality | Sorafenib | ||
| Total, other adverse events | Sunitinib | 515 | 526 |
| Total, other adverse events | Sorafenib | 531 | 542 |
| Total, serious adverse events | Sunitinib | 240 | 526 |
| Total, serious adverse events | Sorafenib | 204 | 542 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sunitinib vs Sorafenib: serious adverse events |
Source 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/NCT00699374
GET https://conductscience.org/api/trials/v1/NCT00699374/events?page=2