Gastric CancerPhase 2ARQ 197-004NCT01152645
Study of ARQ 197 Monotherapy
A Phase 2 study testing ARQ 197 in people with Gastric Cancer, run by Kyowa Kirin Co., Ltd. at 2 sites in 2 countries.
Trial summary
A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Gastric Cancer
- 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
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2010to Aug 2011
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese or Korean with voluntary written informed consent for study participation
- A histologically or cytologically confirmed advanced/recurrent gastric cancer
- One or two prior chemotherapy regimens for advanced/recurrent gastric cancer
- At least one measurable lesion
- ECOG performance status of 0 or 1
- Life expectancy ≥3 months
Who cannot join
- Surgery for cancer within 4 weeks prior to the first dose of ARQ 197
- Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197
- Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197
- Positive for HIV antibody
- Known symptomatic brain metastasis
- Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or operation history for gastrointestinal disorders
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- Uncontrolled concomitant disease
- Patients who wish to have a child and who would not agree to use contraceptive measures
- Pregnant or lactating
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer
A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.
- Conditions
- Gastric Cancer
- Being tested
- ARQ 197
- Keywords
- Advanced/recurrent gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 197Drug
Orally twice daily administration of ARQ 197
| 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.
Antitumor effect
Disease control
Measured: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Secondary outcomes (5)
Antitumor effect
Tumor response
Measured: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Progression-free survival
Measured: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Overall survival
Measured: Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Pharmacokinetic profile
Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197
Measured: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29.
Adverse events
Measured: Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- 31 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
- NCT01152645
- Sponsor's protocol ID
- ARQ 197-004
- Acronym
- ARQ 197-004
- Status last verified
- Mar 2017
- First submitted
- 25 Jun 2010
- Last updated
- 15 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT01152645
- Acronym / sponsor ID
- ARQ 197-004 / ARQ 197-004
- Conditions
- Gastric Cancer
- Keywords
- Advanced/recurrent gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Jun 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.
A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.
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 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Japanese or Korean with voluntary written informed consent for study participation
- A histologically or cytologically confirmed advanced/recurrent gastric cancer
- One or two prior chemotherapy regimens for advanced/recurrent gastric cancer
- At least one measurable lesion
- ECOG performance status of 0 or 1
Key exclusion criteria (9 listed)
- Surgery for cancer within 4 weeks prior to the first dose of ARQ 197
- Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197
- Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197
- Positive for HIV antibody
- Known symptomatic brain metastasis
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 197Orally twice daily administration of ARQ 197 | Drug | ARQ 197 |
Primary outcome
Antitumor effect
Time frame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Disease control
5 secondary outcomes
Antitumor effect
Time frame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Progression-free survival
Time frame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Overall survival
Time frame: Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Pharmacokinetic profile
Time frame: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29.
Adverse events
Time frame: Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study.
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 15 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ 197 in people with Gastric Cancer, run by Kyowa Kirin Co., Ltd. at 2 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 6 inclusion and 9 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 15 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 2 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. 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?
Antitumor effect (time frame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.). 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 15 Mar 2017.