Carcinoma, HepatocellularPhase 2BASILNCT01204177
Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.
A Phase 2 study testing BAY86-9766 MEK Inhibitor + Sorafenib in people with Carcinoma, Hepatocellular, run by Bayer at 15 sites in 4 countries.
Trial summary
This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. 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?
- BAY86-9766 MEK Inhibitor + Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Dec 2010to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 age >/= 18 years of age
- Life expectancy >/= 12 weeks
- Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic
- Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
- Adequate bone marrow, liver and renal function
Who cannot join
- Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
- History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
- Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
- Renal failure requiring hemo- or peritoneal dialysis
- Known human immunodeficiency virus (HIV) infection
- Known history or symptomatic metastatic brain or meningeal tumors
Show all 14Show fewer
- History of organ allograft.
- History of interstitial lung disease (ILD).
- Excluded previous therapies and medications:
- Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy
- Radiotherapy within 4 weeks prior to start of study treatment
- Any other investigational agents within 4 weeks from the first dose of study treatment
- Major surgery within 4 weeks of start of study
- Concomitant use of strong inhibitors and strong inducers of CYP3A4
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
South Korea7 sites
Study site
Busan, 602-739
Study site
Goyang-si, Gyeonggido, 410-769
Study site
Junggu, Daegu Gwang''yeogsi, 700-721
Study site
Seoul, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 135-710
Study site
Seoul, 138-736
Taiwan4 sites
Study site
Kaohsiung City, 833
Study site
Tainan, 736
Study site
Tainan
Study site
Taipei, 100
About this study
Official title: A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- BAY86-9766 MEK Inhibitor + Sorafenib
- Keywords
- Hepatocellular carcinoma (HCC), MEK inhibitor, Sorafenib, Disease control rate (DCR), Safety
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY86-9766 MEK Inhibitor + SorafenibDrug
All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY86-9766 MEK Inhibitor + Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Measured: From first dose of combination treatment until last tumor evaluation
Secondary outcomes (8)
Overall Survival (OS)
Measured: 1st dose of study medication to last date of follow up
Time To Progression (TTP)
Measured: 1st dose of study medication until disease progression
Response Rate (RR)
Measured: 1st dose of study medication until last tumor evaluation
Duration Of Response (DOR)
Measured: 1st dose of study medication until last tumor evaluation
Safety: physical examination, vital signs, adverse events, safety lab
Measured: At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT
Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)
Measured: At day 1 of each cycle and within 7 day after the last treatment
Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)
Measured: Day -3, cycle 2 (day 1)
Biomarkers
Measured: At screening, day 1 of cycle 1 - 4, EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT01204177
- Sponsor's protocol ID
- 14899
- Acronym
- BASIL
- Status last verified
- Sep 2013
- First submitted
- 16 Sep 2010
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim HY, Heo J, Choi HJ, Lin CY, Yoon JH, Hsu C, Rau KM, Poon RT, Yeo W, Park JW, Tay MH, Hsieh WS, Kappeler C, Rajagopalan P, Krissel H, Jeffers M, Yen CJ, Tak WY. A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):5976-85. doi: 10.1158/1078-0432.CCR-13-3445. Epub 2014 Oct 7.
PubMed 25294897
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT01204177
- Acronym / sponsor ID
- BASIL / 14899
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular carcinoma (HCC), MEK inhibitor, Sorafenib, Disease control rate (DCR), Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY86-9766 MEK Inhibitor + Sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female age >/= 18 years of age
- Life expectancy >/= 12 weeks
- Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic
- Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Key exclusion criteria (14 listed)
- Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
- History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
- Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
- Renal failure requiring hemo- or peritoneal dialysis
- Known human immunodeficiency virus (HIV) infection
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 |
|---|---|---|
| BAY86-9766 MEK Inhibitor + SorafenibAll patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression) | Drug | Arm 1 |
Primary outcome
Disease Control Rate (DCR)
Time frame: From first dose of combination treatment until last tumor evaluation
8 secondary outcomes
Overall Survival (OS)
Time frame: 1st dose of study medication to last date of follow up
Time To Progression (TTP)
Time frame: 1st dose of study medication until disease progression
Response Rate (RR)
Time frame: 1st dose of study medication until last tumor evaluation
Duration Of Response (DOR)
Time frame: 1st dose of study medication until last tumor evaluation
Safety: physical examination, vital signs, adverse events, safety lab
Time frame: At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT
Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)
Time frame: At day 1 of each cycle and within 7 day after the last treatment
Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)
Time frame: Day -3, cycle 2 (day 1)
Biomarkers
Time frame: At screening, day 1 of cycle 1 - 4, EOT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
- Derived from this study: PubMed 25294897Lim HY, Heo J, Choi HJ, Lin CY, Yoon JH, Hsu C, Rau KM, Poon RT, Yeo W, Park JW, Tay MH, Hsieh WS, Kappeler C, Rajagopalan P, Krissel H, Jeffers M, Yen CJ, Tak WY. A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):5976-85. doi: 10.1158/1078-0432.CCR-13-3445. Epub 2014 Oct 7.
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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
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY86-9766 MEK Inhibitor + Sorafenib in people with Carcinoma, Hepatocellular, run by Bayer at 15 sites in 4 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 7 inclusion and 14 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 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea, Taiwan, Hong Kong, Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease Control Rate (DCR) (time frame: From first dose of combination treatment until last tumor evaluation). 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 NCT01204177, 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 6 Sep 2013.