Non Small Cell Lung CancerPhase 2NCT00777309
A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing ARQ 197 and Erlotinib in people with Non Small Cell Lung Cancer, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 38 sites in 6 countries.
Trial summary
This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 38 sitesin 6 countries
- Study dates
- Sep 2008to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent prior to study-specific screening procedures
- ≥ 18 years old
- Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
- ≥ one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have included erlotinib or other EGFR inhibiting agent)
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
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- Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
- Females of childbearing potential must have a negative serum pregnancy test
- Good organ function
- Confirmed availability of archival pathology samples (10 unstained paraffin-embedded slides) or tissue block suitable for subsequent analysis of KRAS, EGFR, and c-Met
Who cannot join
- Previous receipt of erlotinib or other EGFR inhibiting therapy
- Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for radiotherapy) prior to the start of designated treatment
- Documented major surgical procedure within 4 weeks prior to randomization.
- Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti-epileptics, or other symptom-relieving medications
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
- Significant gastrointestinal disorder that, in opinion of Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn's disease, small or large bowel resection, malabsorbtion syndrome)
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- Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
- Any known contraindication to treatment with ARQ 197 or erlotinib
- Any known hypersensitivity to any of component of ARQ 197 or erlotinib
- Other malignancy within 5 years of randomization, with the exception of adequately treated intraepithelial carcinoma of the cervix uteri, prostate carcinoma with a PSA value < 0.2 ng/ml or basal or squamous cell carcinoma of the skin
- Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
- Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
United States18 sites
Study site
Atlanta, Georgia, 30309
Study site
Batesville, Indiana, 47006
Study site
Boston, Massachusetts, 02114
Study site
Burbank, California, 91505
Study site
Canton, Ohio, 44718
Study site
Charlotte, North Carolina, 28204
Study site
Chicago, Illinois, 60612
Study site
Corpus Christi, Texas, 78410
Study site
Dallas, Texas, 75246
Study site
Dallas, Texas, 75390
Study site
Houston, Texas, 77024
Study site
Indianapolis, Indiana, 46107
Study site
Jacksonville, Florida, 32204
Study site
Louisville, Kentucky, 40202
Study site
Salt Lake City, Utah, 84114
Study site
Santa Monica, California, 90404
Study site
Torrington, Connecticut, 06790
Study site
Worcester, Massachusetts, 01608
Germany6 sites
Study site
Gauting, 82131
Study site
Großhansdorf, 22927
Study site
Hamburg, 21075
Study site
Mainz, 55131
Study site
Mannheim, 68167
Study site
Villingen-Schwenningen, 78050
Poland6 sites
Study site
Bialystock, 15-027
Study site
Otwock, 05-400
Study site
Poznan, 60-569
Study site
Szczecin, 70-891
Study site
Torun, 87-100
Study site
Wroclaw, 53-439
Russia5 sites
Central Clinical Hospital #1
Moscow, 125367
Central Clinical Hospital #2
Moscow, 129128
Study site
Saint Petersburg, 197002
Study site
Saint Petersburg, 197089
Study site
Saint Petersgurg, 197758
About this study
Official title: A Randomized Phase 2 Study of Erlotinib Plus ARQ 197 Versus Erlotinib Plus Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.
Read the detailed description
This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC. The study will evaluate progression-free survival between the two arms.
A total of 154 patients will be enrolled.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- ARQ 197, Erlotinib, Placebo
- Keywords
- NSCLC
- 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 197Drug
Also called Tivantinib
360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
ErlotinibDrug
Also called Tarceva
Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
PlaceboDrug
The placebo is provided as a capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily. Receives: Drug: ARQ 197; Drug: Erlotinib |
| 2 | Active comparator | Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily Receives: Drug: Erlotinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo
Secondary outcomes (3)
Evaluate overall survival (OS)
Overall response rate (ORR)
Safety of ARQ 197 in combination with erlotinib in patients with NSCLC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMay 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 Non Small Cell Lung 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 167 participants (actual)
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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777309
- Sponsor's protocol ID
- ARQ 197-209
- Status last verified
- Feb 2013
- First submitted
- 21 Oct 2008
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Erlotinib Plus ARQ 197 Versus Erlotinib Plus Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00777309
- Acronym / sponsor ID
- ARQ 197-209
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- 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
- Sep 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Oct 2008 (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 randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.
Detailed description
This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC. The study will evaluate progression-free survival between the two arms.
A total of 154 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ARQ 197, Drug: ErlotinibErlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily. |
| 2 | Active comparator | Drug: Erlotinib, Drug: PlaceboErlotinib (150 mg) once daily plus ARQ 197 placebo twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide signed and dated informed consent prior to study-specific screening procedures
- ≥ 18 years old
- Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
- ≥ one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have included erlotinib or other EGFR inhibiting agent)
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Key exclusion criteria (13 listed)
- Previous receipt of erlotinib or other EGFR inhibiting therapy
- Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for radiotherapy) prior to the start of designated treatment
- Documented major surgical procedure within 4 weeks prior to randomization.
- Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti-epileptics, or other symptom-relieving medications
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
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: Tivantinib360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met | Drug | 1 |
| ErlotinibAlso: TarcevaErlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met. | Drug | 1, 2 |
| PlaceboThe placebo is provided as a capsule | Drug | 2 |
Primary outcome
Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo
3 secondary outcomes
Evaluate overall survival (OS)
Overall response rate (ORR)
Safety of ARQ 197 in combination with erlotinib in patients with NSCLC
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 28 Feb 2013.
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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.
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ 197 and Erlotinib in people with Non Small Cell Lung Cancer, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 38 sites in 6 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 10 inclusion and 13 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 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Germany, Poland, Russia, Latvia and 1 more country. 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?
Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo. 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 28 Feb 2013.