Advanced/Recurrent Non-small-cell Lung CancerPhase 1NCT01251796
A Study of ARQ 197 in Combination With Erlotinib
A Phase 1 study testing ARQ 197 and Erlotinib in people with Advanced/Recurrent Non-small-cell Lung Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced/Recurrent Non-small-cell Lung Cancer
- What is being tested?
- ARQ 197 and Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2010to Nov 2012
- 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
- Voluntary written informed consent for study participation must be obtained
- A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
- History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
- ECOG PS of 0 or 1
- Life expectancy of ≥3 months
- Poor metabolizers as defined by CYP2C19 genotype
Who cannot join
- Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
- Surgery for cancer within 28 days prior to ARQ 197 dose
- Active double cancer
- Known symptomatic brain metastases
- An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
- Pregnant or lactating
- Subjects who wish to have a child and who would not agree to use contraceptive measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.
- Being tested
- ARQ 197 and Erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 197 and ErlotinibDrug
Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| ARQ 197 and Erlotinib | Experimental | ARQ 197 and erlotinib hydrochloride Receives: Drug: ARQ 197 and Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
Measured: DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
Secondary outcomes (3)
Pharmacokinetic profile of ARQ 197
Summary statistics of plasma concentration and pharmacokinetic parameters
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, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Pharmacokinetic profile of Erlotinib
Summary statistics of plasma concentration and pharmacokinetic parameters
Measured: At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Antitumor activity
Response rate
Measured: Baseline, and then every 6 week of imaging until discontinuation criteria met
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Recurrent Non-small-cell Lung 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 9 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
- NCT01251796
- Sponsor's protocol ID
- ARQ 197-005
- Status last verified
- Mar 2017
- First submitted
- 29 Nov 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
- A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01251796
- Acronym / sponsor ID
- ARQ 197-005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Dec 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 is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ 197 and Erlotinib | Experimental | Drug: ARQ 197 and ErlotinibARQ 197 and erlotinib hydrochloride |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary written informed consent for study participation must be obtained
- A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
- History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
- ECOG PS of 0 or 1
- Life expectancy of ≥3 months
Key exclusion criteria (7 listed)
- Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
- Surgery for cancer within 28 days prior to ARQ 197 dose
- Active double cancer
- Known symptomatic brain metastases
- An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
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 197 and ErlotinibOrally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride | Drug | ARQ 197 and Erlotinib |
Primary outcome
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
Time frame: DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
3 secondary outcomes
Pharmacokinetic profile of ARQ 197
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, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Pharmacokinetic profile of Erlotinib
Time frame: At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Antitumor activity
Time frame: Baseline, and then every 6 week of imaging until discontinuation criteria met
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.
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 and Erlotinib in people with Advanced/Recurrent Non-small-cell Lung 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 6 inclusion and 7 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 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?
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib (time frame: DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.). 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.