Advanced Hepatocellular CarcinomaPhase 1NCT01656265
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
A Phase 1 study testing ARQ 197 in people with Advanced Hepatocellular Carcinoma, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- ARQ 197
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2012to Mar 2014
- Phase
- Phase 1
- 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
- Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Child-Pugh classification A at the time of registration
- Adequate bone marrow, liver, and renal functions within 14 days prior to registration
Who cannot join
- Prior therapy with a c-Met inhibitor (including ARQ 197)
- Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks
- Local treatment for malignancy within 4 weeks prior to registration
- Major surgical procedure within 4 weeks prior to registration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma
The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- ARQ 197
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 197Drug
Also called Tivantinib
Daily repeating dose of oral ARQ 197, twice a day just after meals. Dose of ARQ 197 will be escalated according to 3+3 rule.
| Study group | Role | What they receive |
|---|---|---|
| ARQ 197 | Experimental | Not described Receives: Drug: ARQ 197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
Adverse Event collection and assessment will be done for all treated subjects to assess the safety, tolerability. The grading for the severity of the adverse events will be determined according to CTCAE ver 4.0.
Measured: DLT observation period will be the first 28 days after the start of ARQ 197 treatment.
Secondary outcomes (2)
Profiles of Pharmacokinetics
maximum concentration (Cmax), area under the curve (AUC), half-life (t1/2), apparent clearance (Cl/F), and apparent volume of distribution in the terminal elimination phase (Vz/F).
Measured: Plasma sample correction at pre-dose 1, 2, 4, 6, 10, 12 and 24 hours on day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on day 15; and at pre-dose on day 29.
Antitumor effects according to RECIST 1.1.
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01656265
- Sponsor's protocol ID
- ARQ 197-008
- Status last verified
- Feb 2017
- First submitted
- 20 Jul 2012
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01656265
- Acronym / sponsor ID
- ARQ 197-008
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Aug 2012 (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 purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ 197 | Experimental | Drug: ARQ 197 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Child-Pugh classification A at the time of registration
- Adequate bone marrow, liver, and renal functions within 14 days prior to registration
Key exclusion criteria (4 listed)
- Prior therapy with a c-Met inhibitor (including ARQ 197)
- Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks
- Local treatment for malignancy within 4 weeks prior to registration
- Major surgical procedure within 4 weeks prior to registration
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 |
|---|---|---|
| ARQ 197Also: TivantinibDaily repeating dose of oral ARQ 197, twice a day just after meals. Dose of ARQ 197 will be escalated according to 3+3 rule. | Drug | ARQ 197 |
Primary outcome
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
Time frame: DLT observation period will be the first 28 days after the start of ARQ 197 treatment.
Adverse Event collection and assessment will be done for all treated subjects to assess the safety, tolerability. The grading for the severity of the adverse events will be determined according to CTCAE ver 4.0.
2 secondary outcomes
Profiles of Pharmacokinetics
Time frame: Plasma sample correction at pre-dose 1, 2, 4, 6, 10, 12 and 24 hours on day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on day 15; and at pre-dose on day 29.
Antitumor effects according to RECIST 1.1.
Time frame: Every 6 weeks
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 3 Mar 2017.
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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 1 study testing ARQ 197 in people with Advanced Hepatocellular Carcinoma, 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 4 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 3 Mar 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability (time frame: DLT observation period will be the first 28 days after the start of ARQ 197 treatment.). 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 3 Mar 2017.