Trial · NCT01232296
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
NCT01232296, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-12-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment. Trials, record NCT01232296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01232296
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
- NCT number
- NCT01232296
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 162 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hepatocellular Carcinoma
- Interventions
- dovitinib, sorafenib
- First posted
- 2010-11-02
- Last updated
- 2015-12-04
- Results first posted
- 2015-12-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival - Overall Survival | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first. | The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed |
| Secondary | Time to Tumor Progression (Tumor Assessment) | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first. | Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). For target lesions, disease progression mean at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression refers to unequivocal progression of existing non-target lesions. In addition, the appearance of new lesions is always considered as disease progression. |
| Secondary | Disease Control Rate (Tumor Assessment) | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first. | Disease Control Rate (DCR) is defined as the proportion of patients whose best overall response is either complete response \[CR\], partial response \[PR\] or stable disease \[SD\] according to RECIST 1.1. |
| Secondary | Time to Definitive Deterioration in ECOG Performance Status (PS) | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first | Time to definitive deterioration on ECOG PS scale (by at least one point) was defined as the time from the date of randomization to the date of definitive deterioration of the ECOG PS by at least one category of the score from baseline or to the date of death whichever occurred earlier. 0 is Fully active, able to carry on all pre-disease performance without restriction, 1 is Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work and 2 is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. |
| Secondary | Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258 | Week 1 day 1, week 4 day 5 | Cmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1). |
| Secondary | Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258 | Week 1 day 1, week 4 day 5 | Tmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Tmax is the time to to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (time) |
| Secondary | Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258 | Week 1 day 1, week 4 day 5 | The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival - Overall Survival | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first. | The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. | Weeks | MEDIAN |
| SECONDARY | Time to Tumor Progression (Tumor Assessment) | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first. | The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. | Weeks | MEDIAN |
| SECONDARY | Disease Control Rate (Tumor Assessment) | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first. | The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. | Participants | NUMBER |
| SECONDARY | Time to Definitive Deterioration in ECOG Performance Status (PS) | Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first | The Full Analysis Set (FAS): all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. Only Total number of definitive deterioration events included in the analysis | Weeks | MEDIAN |
| SECONDARY | Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258 | Week 1 day 1, week 4 day 5 | The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile | (ng/mL) | MEAN |
| SECONDARY | Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258 | Week 1 day 1, week 4 day 5 | The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile | hours | MEDIAN |
| SECONDARY | Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258 | Week 1 day 1, week 4 day 5 | The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile | (ng.h/mL) | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival - Overall Survival | TKI258 | 33 | 95% Confidence Interval 25.7 to 39 | Weeks | |
| Overall Survival - Overall Survival | Sorafenib | 39.4 | 95% Confidence Interval 22.6 to 56.1 | Weeks | |
| Time to Tumor Progression (Tumor Assessment) | TKI258 | 17.6 | 95% Confidence Interval 12.3 to 18.4 | Weeks | |
| Time to Tumor Progression (Tumor Assessment) | Sorafenib | 17.9 | 95% Confidence Interval 12.3 to 18.9 | Weeks | |
| Disease Control Rate (Tumor Assessment) | TKI258 | Complete response (CR) | 0 | Participants | |
| Disease Control Rate (Tumor Assessment) | Sorafenib | Complete response (CR) | 1 | Participants | |
| Disease Control Rate (Tumor Assessment) | TKI258 | Partial response (PR) | 5 | Participants | |
| Disease Control Rate (Tumor Assessment) | Sorafenib | Partial response (PR) | 8 | Participants | |
| Disease Control Rate (Tumor Assessment) | TKI258 | Stable disease (SD) | 42 | Participants | |
| Disease Control Rate (Tumor Assessment) | Sorafenib | Stable disease (SD) | 44 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TKI258 | 82 | |
| Overall Study | STARTED | Sorafenib | 83 | |
| Overall Study | Full Analysis Set | TKI258 | 82 | |
| Overall Study | Full Analysis Set | Sorafenib | 83 | |
| Overall Study | Safety Set | TKI258 | 79 | |
| Overall Study | Safety Set | Sorafenib | 83 | |
| Overall Study | COMPLETED | TKI258 | 0 | |
| Overall Study | COMPLETED | Sorafenib | 0 | |
| Overall Study | NOT COMPLETED | TKI258 | 82 | |
| Overall Study | NOT COMPLETED | Sorafenib | 83 |
Source ClinicalTrials.gov
Adverse events284
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 | TKI258 | 10 | 79 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Sorafenib | 7 | 83 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | TKI258 | 4 | 79 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Sorafenib | 0 | 83 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | TKI258 | 8 | 79 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Sorafenib | 2 | 83 | |
| other | TINNITUS | Ear and labyrinth disorders | TKI258 | 5 | 79 | |
| other | TINNITUS | Ear and labyrinth disorders | Sorafenib | 0 | 83 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | TKI258 | 7 | 79 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Sorafenib | 8 | 83 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TKI258 | ||
| Total, all-cause mortality | Sorafenib | ||
| Total, other adverse events | TKI258 | 77 | 79 |
| Total, other adverse events | Sorafenib | 80 | 83 |
| Total, serious adverse events | TKI258 | 40 | 79 |
| Total, serious adverse events | Sorafenib | 34 | 83 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| TKI258 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/NCT01232296
GET https://conductscience.org/api/trials/v1/NCT01232296/results?page=2