Carcinoma, HepatocellularPhase 3NCT00494299
Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 75 sites in 2 countries.
Trial summary
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 458 participants
- Where
- 75 sitesin 2 countries
- Study dates
- Apr 2006to Nov 2010
- Phase
- Phase 3
- 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
- Male or female
- Aged of 18 and over
- Advanced hepatocellular carcinoma
Who cannot join
- History of prior systemic chemotherapy
- Failure in vital organ
Trial locations and contacts
75 sites in 2 countries.
75 sites in 2 countries
Japan68 sites
Study site
Akashi, Hyōgo, 673-8558
Study site
Chiba, Chiba, 260-8677
Study site
Chūō, Yamanashi, 409-3898
Study site
Chuo-ku, Tokyo, 104-0045
Study site
Fukui-shi, Fukui, 918-8503
Study site
Fukuoka, Fukuoka, 814-0180
Study site
Gifu, Gifu, 500-8513
Study site
Hiroshima, Hiroshima, 730-8619
Study site
Hiroshima, Hiroshima, 734-8530
Study site
Hiroshima, Hiroshima, 734-8551
Study site
Iizuka, Fukuoka, 820-8505
Study site
Isehara, Kanagawa, 259-1193
Study site
Isesaki, Gunma, 372-0817
Study site
Izunokuni, Shizuoka, 410-2295
Study site
Kagoshima, Kagoshima-ken, 890-0061
Study site
Kagoshima, Kagoshima-ken, 890-8520
Study site
Kagoshima, Kagoshima-ken, 892-8512
Study site
Kanazawa, Ishikawa-ken, 920-8641
Study site
Kasama, Ibaraki, 309-1793
Study site
Kashiwa, Chiba, 277-8577
Study site
Kawachi-Nagano, Osaka, 586-8521
Study site
Kitakyushu, Fukuoka, 802-8533
Study site
Kitakyushu, Fukuoka, 807-8555
Study site
Kobe, Hyōgo, 650-0017
Study site
Kumamoto, Kumamoto, 860-0008
Study site
Kumamoto, Kumamoto, 860-8556
Study site
Kumamoto, Kumamoto, 861-4193
Study site
Kure, Hiroshima, 737-0193
Study site
Kurume, Fukuoka, 830-0011
Study site
Kyoto, Kyoto, 606-8507
Study site
Maebashi, Gunma, 371-8511
Study site
Matsumoto, Nagano, 390-8621
Study site
Matsuyama, Ehime, 791-0280
Study site
Meguro-ku, Tokyo, 152-8902
Study site
Minato-ku, Tokyo, 105-8470
Study site
Miyazaki, Miyazaki, 880-0003
Study site
Moriguchi, Osaka, 570-8507
Study site
Musashino, Tokyo, 180-8610
Study site
Nagoya, Aichi-ken, 460-0001
Study site
Nerima-ku, Tokyo, 177-8521
Study site
Okayama, Okayama-ken, 700-8511
Study site
Ōmura, Nagasaki, 856-8562
Study site
Osaka, Osaka, 530-8480
Study site
Osaka, Osaka, 534-0021
Study site
Osaka, Osaka, 537-8511
Study site
Osaka, Osaka, 540-0006
Study site
Osaka, Osaka, 543-8555
Study site
Osaka, Osaka, 545-8586
Study site
Osaka, Osaka, 558-8558
Study site
Sagamihara, Kanagawa, 228-8520
Study site
Sapporo, Hokkaido, 003-0804
Study site
Sapporo, Hokkaido, 060-0033
Study site
Sayama, Osaka, 589-8511
Study site
Sendai, Miyagi, 980-8574
Study site
Sendai, Miyagi, 983-8520
Study site
Shimonoseki, Yamaguchi, 750-0061
Study site
Shimotsuke, Tochigi, 329-0498
Study site
Shinjuku-ku, Tokyo, 160-0023
Study site
Suita, Osaka, 565-0871
Study site
Sunto, Shizuoka, 411-8777
Study site
tabashi City, Tokyo, 173-8610
Study site
Tōon, Ehime, 791-0295
Study site
Toyama, Toyama, 930-8550
Study site
Ube, Yamaguchi, 755-8505
Study site
Yamagata, Yamagata, 990-9585
Study site
Yokohama, Kanagawa, 232-0024
Study site
Yokohama, Kanagawa, 245-8575
Study site
Yonago, Tottori, 683-8504
South Korea7 sites
Study site
Daegu, 700-721
Study site
Incheon, 405-760
Study site
Seoul, Seoul Teugbyeolsi, 152-703
Study site
Seoul, 110-744
Study site
Seoul, 135710
Study site
Seoul, 138-736
Study site
Seoul
About this study
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Sorafenib (Nexavar, BAY43-9006), Placebo
- Keywords
- HCC, Cancer, Liver Cancer, TACE
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
PlaceboDrug
Placebo: matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
| Placebo | Placebo comparator | Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (TTP)
Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Measured: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Secondary outcomes (1)
Overall Survival (OS)
Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.
Measured: From randomization of the first subject until 39 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startApr 2006
- Primary completionJul 2009
- Study completionNov 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by BayerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494299
- Sponsor's protocol ID
- 11721
- Status last verified
- Nov 2013
- First submitted
- 28 Jun 2007
- Last updated
- 20 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. doi: 10.1016/j.ejca.2011.05.007.
PubMed 21664811
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
- ClinicalTrials.gov ID
- NCT00494299
- Acronym / sponsor ID
- 11721
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- HCC, Cancer, Liver Cancer, TACE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 20 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006)Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. |
| Placebo | Placebo comparator | Drug: PlaceboSorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female
- Aged of 18 and over
- Advanced hepatocellular carcinoma
Key exclusion criteria (2 listed)
- History of prior systemic chemotherapy
- Failure in vital organ
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 |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib | Drug | Sorafenib (Nexavar, BAY43-9006) |
| PlaceboPlacebo: matching placebo | Drug | Placebo |
Primary outcome
Time to Progression (TTP)
Time frame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
1 secondary outcome
Overall Survival (OS)
Time frame: From randomization of the first subject until 39 months later.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21664811Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. doi: 10.1016/j.ejca.2011.05.007.
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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.
Bayer Study Director study director
Bayer
75 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 75 sites in 2 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 3 inclusion and 2 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 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Japan, South Korea. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 20 Jan 2011). 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?
Time to Progression (TTP) (time frame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00494299, which also lists 1 linked publication.
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 20 Dec 2013.