Liver CancerPhase 3JET-HCCNCT02029157
A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)
A Phase 3 study testing ARQ197 in people with Liver Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- ARQ197
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to Aug 2017
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent form
- ≥20 years old
- Inoperable HCC which is not eligible for locoregional therapy
- Diagnosed as c-Met high in tumor sample
- Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1
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- Child-Pugh Class A
- Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1,
- Negative pregnancy test results
- Adequate organ function
- Life expectancy of at least 12 weeks
Who cannot join
- More than 2 prior systemic chemotherapy.
- Prior therapy of c-Met inhibitor (including antibody)
- Any systemic therapy within ≤2 weeks prior to the randomization
- Locoregional therapy within ≤4 weeks prior to randomization.
- Major surgery within ≤4 weeks prior to the randomization
- Concurrent cancer within ≤5 years prior to the randomization
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- History of cardiac diseases
- Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0
- Any psychological disorder affecting Informed Consent
- Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody
- Blood or albumin transfusion within ≤14 days prior to the screening test
- Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV)
- Symptomatic brain metastases
- History of liver transplantation
- Inability to swallow oral medications
- Confirmed interstitial lung disease
- Pleural effusion and/or clinically significant ascites
- Pregnancy or breast-feeding
- Without consent to effective single or combined contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomized Double-blind, Placebo-controlled Trial of ARQ 197 in Subjects With c-MET Diagnostic-high Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Sorafenib Therapy
The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.
- Conditions
- Liver Cancer
- Being tested
- ARQ197, Placebo
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ197Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ARQ 197 | Experimental | Daily oral dose Receives: Drug: ARQ197 |
| Placebo | Placebo comparator | Daily oral dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival will be compared between ARQ 197 group and Placebo group, to prove the efficacy of ARQ 197 in the population.
Measured: Estimated median of 8-12 weeks in PFS
Secondary outcomes (1)
Overall survival
The date of the events was followed every three months after the end of the treatments of the study drug.
Measured: Estimated median of 24 weeks in overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2017
- Study completionAug 2017
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 Liver CancerStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029157
- Sponsor's protocol ID
- ARQ 197-009
- Acronym
- JET-HCC
- Status last verified
- Oct 2017
- First submitted
- 27 Dec 2013
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kudo M, Morimoto M, Moriguchi M, Izumi N, Takayama T, Yoshiji H, Hino K, Oikawa T, Chiba T, Motomura K, Kato J, Yasuchika K, Ido A, Sato T, Nakashima D, Ueshima K, Ikeda M, Okusaka T, Tamura K, Furuse J. A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma. Cancer Sci. 2020 Oct;111(10):3759-3769. doi: 10.1111/cas.14582. Epub 2020 Aug 26.
PubMed 32716114
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double-blind, Placebo-controlled Trial of ARQ 197 in Subjects With c-MET Diagnostic-high Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Sorafenib Therapy
- ClinicalTrials.gov ID
- NCT02029157
- Acronym / sponsor ID
- JET-HCC / ARQ 197-009
- Conditions
- Liver Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 7 Jan 2014 (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.
The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARQ 197 | Experimental | Drug: ARQ197Daily oral dose |
| Placebo | Placebo comparator | Drug: PlaceboDaily oral dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent form
- ≥20 years old
- Inoperable HCC which is not eligible for locoregional therapy
- Diagnosed as c-Met high in tumor sample
- Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.
Key exclusion criteria (19 listed)
- More than 2 prior systemic chemotherapy.
- Prior therapy of c-Met inhibitor (including antibody)
- Any systemic therapy within ≤2 weeks prior to the randomization
- Locoregional therapy within ≤4 weeks prior to randomization.
- Major surgery within ≤4 weeks prior to the randomization
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 |
|---|---|---|
| ARQ197 | Drug | ARQ 197 |
| Placebo | Drug | Placebo |
Primary outcome
Progression-free survival (PFS)
Time frame: Estimated median of 8-12 weeks in PFS
Progression-free survival will be compared between ARQ 197 group and Placebo group, to prove the efficacy of ARQ 197 in the population.
1 secondary outcome
Overall survival
Time frame: Estimated median of 24 weeks in overall survival
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 9 Oct 2017.
- Derived from this study: PubMed 32716114Kudo M, Morimoto M, Moriguchi M, Izumi N, Takayama T, Yoshiji H, Hino K, Oikawa T, Chiba T, Motomura K, Kato J, Yasuchika K, Ido A, Sato T, Nakashima D, Ueshima K, Ikeda M, Okusaka T, Tamura K, Furuse J. A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma. Cancer Sci. 2020 Oct;111(10):3759-3769. doi: 10.1111/cas.14582. Epub 2020 Aug 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARQ197 in people with Liver Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 11 inclusion and 19 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
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?
Progression-free survival (PFS) (time frame: Estimated median of 8-12 weeks in PFS). 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 NCT02029157, 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 9 Oct 2017.