Hepatocellular CarcinomaPhase 2NCT01232296
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
A Phase 2 study testing dovitinib and sorafenib in people with Hepatocellular Carcinoma, run by Novartis Pharmaceuticals at 24 sites in 7 countries.
Trial summary
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- dovitinib and sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 24 sitesin 7 countries
- Study dates
- Jul 2011to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines
- Advance HCC Stage B and C according to BCLC staging classification
- Child Pugh A
- At least one measurable lesion as assessed by CT or MRI
- ECOG PS of 0 or 1
- Adequate bone marrow, liver, and renal function
Who cannot join
- Prior systemic therapy for HCC
- Brain metastases
- Active bleeding (including variceal bleeding as the result of esophageal varices) Patients who have received a liver transplant or are awaiting an immediate transplant
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
South Korea5 sites
Novartis Investigative Site
Seoul, Korea, 03722
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, 136-705
Thailand5 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
Novartis Investigative Site
Khon Kaen, 40002
Novartis Investigative Site
Songkhla, 90110
China4 sites
Novartis Investigative Site
Beijing, 100039
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Nanjing, Jiangsu, 210002
Novartis Investigative Site
Xi’an, Shanxi, 710032
Taiwan4 sites
Novartis Investigative Site
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 33305
Novartis Investigative Site
Taichung, Taiwan, 40705
Novartis Investigative Site
Taipei, Taiwan, 10048
Novartis Investigative Site
Taipei, Taiwan, ROC, 112
Japan3 sites
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Sayama, Osaka, 589-8511
Novartis Investigative Site
Yokohama, Kanagawa, 232-0024
Hong Kong2 sites
Novartis Investigative Site
Hong Kong
Novartis Investigative Site
Shatin, New Territories, Hong Kong
About this study
Official title: An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- dovitinib, sorafenib
- Keywords
- Hepatocellular Carcinoma, HCC, Liver cancer, Child Pugh A, HCC Stage C
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dovitinibDrug
Also called TKI258
500 mg p.o. o.d. 5 days on/2 days off
sorafenibDrug
400 mg p.o. b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| TKI258 | Experimental | capsule Receives: Drug: dovitinib |
| Sorafenib | Experimental | tablet Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival - Overall Survival
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
Measured: 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.
Secondary outcomes (6)
Time to Tumor Progression (Tumor Assessment)
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.
Measured: 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 (Tumor Assessment)
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.
Measured: 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 in ECOG Performance Status (PS)
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.
Measured: 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
Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258
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).
Measured: Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258
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)
Measured: Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258
The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)
Measured: Week 1 day 1, week 4 day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232296
- Sponsor's protocol ID
- CTKI258A2208
- Status last verified
- Nov 2015
- First submitted
- 30 Sep 2010
- Last updated
- 4 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01232296
- Acronym / sponsor ID
- CTKI258A2208
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, HCC, Liver cancer, Child Pugh A, HCC Stage C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 4 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKI258 | Experimental | Drug: dovitinibcapsule |
| Sorafenib | Experimental | Drug: sorafenibtablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines
- Advance HCC Stage B and C according to BCLC staging classification
- Child Pugh A
- At least one measurable lesion as assessed by CT or MRI
- ECOG PS of 0 or 1
Key exclusion criteria (4 listed)
- Prior systemic therapy for HCC
- Brain metastases
- Active bleeding (including variceal bleeding as the result of esophageal varices) Patients who have received a liver transplant or are awaiting an immediate transplant
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dovitinibAlso: TKI258500 mg p.o. o.d. 5 days on/2 days off | Drug | TKI258 |
| sorafenib400 mg p.o. b.i.d. | Drug | Sorafenib |
Primary outcome
Overall Survival - Overall Survival
Time frame: 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
6 secondary outcomes
Time to Tumor Progression (Tumor Assessment)
Time frame: 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 (Tumor Assessment)
Time frame: 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 in ECOG Performance Status (PS)
Time frame: 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
Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258
Time frame: Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258
Time frame: Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258
Time frame: Week 1 day 1, week 4 day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dovitinib and sorafenib in people with Hepatocellular Carcinoma, run by Novartis Pharmaceuticals at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea, Thailand, China, Taiwan, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival - Overall Survival (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.