CancerPhase 1NCT00302172
ARQ 197 in Subjects With Metastatic Solid Tumors
A Phase 1 study testing ARQ 197 in people with Cancer and Tumor, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 3 sites in United States.
Trial summary
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 78 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent must be obtained and documented according to ICH GCP, the local regulatory requirements, and permission to use private health information in accordance with HIPPA prior to study-specific screening procedures
- A histologically or cytologically confirmed RCC or other c-Met expression tumors that is metastatic
- Patient must have available archival tumor tissue or accessible tumor that is safely amenable to tumor biopsy
- ≥ 18 years of age
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
- Karnofsky performance status ≥ 70%
Show all 14Show fewer
- Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
- Females of childbearing potential must have a negative serum pregnancy test
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5.0 × ULN with metastatic liver disease.
- Hemoglobin (Hgb) ≥ 10 g/dl
- Total bilirubin ≤ 1.5 × ULN
- Creatinine ≤ 1.5 x ULN
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
Who cannot join
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose
- Surgery within 4 weeks prior to first dose
- Known brain metastases
- Pregnant or breastfeeding
- Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
- Unable or unwilling to swallow ARQ 197 capsules twice daily
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
- Bradycardia at baseline or known history of arrhythmia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Cleveland Clinic
Cleveland, Ohio, 44195
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Premiere Oncology
Santa Monica, California, 90404
About this study
Official title: A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.
Read the detailed description
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given orally. This is an open label, dose escalation study of ARQ 197 administered orally at a starting dose of 10 mg bid (20 mg/day).
- Being tested
- ARQ 197
- Keywords
- Cancer, solid tumor, metastatic, primary tumor
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 197Drug
Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days).
Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks.
All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted.
| 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.
safety, tolerability
Measured: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
Secondary outcomes (3)
To determine the pharmacokinetic profile of ARQ 197.
Measured: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
To determine the pharmacodynamics (i.e., identify biomarkers) of ARQ 197.
Measured: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
To assess the preliminary anti-tumor activity of ARQ 197.
Measured: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302172
- Sponsor's protocol ID
- ARQ 197-101
- Status last verified
- Aug 2009
- First submitted
- 10 Mar 2006
- Last updated
- 26 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00302172
- Acronym / sponsor ID
- ARQ 197-101
- Keywords
- Cancer, solid tumor, metastatic, primary tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 14 Mar 2006 (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.
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.
Detailed description
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given orally. This is an open label, dose escalation study of ARQ 197 administered orally at a starting dose of 10 mg bid (20 mg/day).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed written informed consent must be obtained and documented according to ICH GCP, the local regulatory requirements, and permission to use private health information in accordance with HIPPA prior to study-specific screening procedures
- A histologically or cytologically confirmed RCC or other c-Met expression tumors that is metastatic
- Patient must have available archival tumor tissue or accessible tumor that is safely amenable to tumor biopsy
- ≥ 18 years of age
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
Key exclusion criteria (8 listed)
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose
- Surgery within 4 weeks prior to first dose
- Known brain metastases
- Pregnant or breastfeeding
- Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
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 197Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days). Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks. All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted. | Drug | ARQ 197 |
Primary outcome
safety, tolerability
Time frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
3 secondary outcomes
To determine the pharmacokinetic profile of ARQ 197.
Time frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
To determine the pharmacodynamics (i.e., identify biomarkers) of ARQ 197.
Time frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
To assess the preliminary anti-tumor activity of ARQ 197.
Time frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is 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 26 Aug 2009.
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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.
3 sites 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 Cancer and Tumor, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 3 sites in United States.
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 14 inclusion and 8 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 26 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
safety, tolerability (time frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is 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 26 Aug 2009.