Advanced Solid TumorsPhase 1NCT00959127
A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer
A Phase 1 study testing ARRY-438162 (MEK162), MEK inhibitor; oral in people with Advanced Solid Tumors and Advanced or Metastatic Biliary Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 10 sites in United States.
Trial summary
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162). This study has 3 parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug in order to achieve the highest dose of the study drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer, Metastatic Colorectal Cancer
- What is being tested?
- ARRY-438162 (MEK162), MEK inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2009to Jan 2013
- 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
- A histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma which is metastatic (measurable disease).
- Documented KRAS- or BRAF- tumor mutation.
- Previously treated with or unsuitable for treatment with 5-Fluorouracil (5-FU), oxaliplatin, irinotecan and, if available, bevacizumab.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Additional criteria exist.
Who cannot join
- Uncontrolled or symptomatic brain metastases (if the patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
- History of central serous retinopathy, retinopathy visible at baseline that would be considered a risk factor for central serous retinopathy or retinal vein occlusion.
- Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of enrollment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stage A low grade prostate cancer may enroll irrespective of the time of diagnosis.
- Prior treatment with a MEK inhibitor.
- Treatment with prior chemotherapy, anticancer immunotherapy, monoclonal antibodies or other protein or peptide therapeutics within 21 days of the first dose of study drug.
- Treatment with a small molecule targeted agent or anticancer hormonal therapy within 14 days of the first dose of study drug.
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- Treatment with prior radiotherapy within 28 days of initiating study drug (if the radiation portal covered ≤ 10% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
- Major surgery within 4 weeks or minor surgery within 7 days prior to the first dose of study drug.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
- Additional criteria exist.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
University of Colorado Cancer Center
Aurora, Colorado, 80045
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-1000
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43221
MD Anderson Cancer Center
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162).
This study has 3 parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1. (Active, not recruiting)
Read more
In the second part of the study, patients with advanced or metastatic biliary cancer will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients from the US will be enrolled in Part 2. (Active, not recruiting)
In the third part of the study, patients with metastatic colorectal cancer (CRC) will receive the best dose of the study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients with KRAS mutation (Active, not recruiting) and 15 patients with BRAF mutation (Active, not recruiting) from the US will be enrolled in Part 3.
- Conditions
- Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer, Metastatic Colorectal Cancer
- Being tested
- ARRY-438162 (MEK162), MEK inhibitor; oral
- Keywords
- Colorectal Adenocarcinoma, Colon Cancer, Rectal Cancer
- Medical subject headings
- Biliary Tract Neoplasms, Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-438162 (MEK162), MEK inhibitor; oralDrug
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
| Study group | Role | What they receive |
|---|---|---|
| ARRY-438162 (MEK 162) | Experimental | Not described Receives: Drug: ARRY-438162 (MEK162), MEK inhibitor; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the maximum tolerated dose (MTD) of the study drug.
Measured: Part 1, one year
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Parts 1, 2 and 3: two years
Characterize the pharmacokinetics (PK) of the study drug and metabolite.
Measured: Parts 1, 2 and 3: two years
Secondary outcomes (2)
Assess the efficacy of the study drug in terms of tumor response, duration of response, duration of stable disease, progression-free survival and overall survival.
Measured: Parts 1, 2 and 3: two years
Assess possible PK/pharmacodynamic (PD) or PK/efficacy and safety correlations.
Measured: Parts 1, 2 and 3: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959127
- Sponsor's protocol ID
- ARRAY-162-111
- Status last verified
- Sep 2020
- First submitted
- 13 Aug 2009
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00959127
- Acronym / sponsor ID
- ARRAY-162-111
- Conditions
- Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer, Metastatic Colorectal Cancer
- Keywords
- Colorectal Adenocarcinoma, Colon Cancer, Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Aug 2009 (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 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162).
This study has 3 parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1. (Active, not recruiting)
In the second part of the study, patients with advanced or metastatic biliary cancer will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients from the US will be enrolled in Part 2. (Active, not recruiting)
In the third part of the study, patients with metastatic colorectal cancer (CRC) will receive the best dose of the study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients with KRAS mutation (Active, not recruiting) and 15 patients with BRAF mutation (Active, not recruiting) from the US will be enrolled in Part 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARRY-438162 (MEK 162) | Experimental | Drug: ARRY-438162 (MEK162), MEK inhibitor; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma which is metastatic (measurable disease).
- Documented KRAS- or BRAF- tumor mutation.
- Previously treated with or unsuitable for treatment with 5-Fluorouracil (5-FU), oxaliplatin, irinotecan and, if available, bevacizumab.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Additional criteria exist.
Key exclusion criteria (10 listed)
- Uncontrolled or symptomatic brain metastases (if the patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
- History of central serous retinopathy, retinopathy visible at baseline that would be considered a risk factor for central serous retinopathy or retinal vein occlusion.
- Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of enrollment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stage A low grade prostate cancer may enroll irrespective of the time of diagnosis.
- Prior treatment with a MEK inhibitor.
- Treatment with prior chemotherapy, anticancer immunotherapy, monoclonal antibodies or other protein or peptide therapeutics within 21 days of the first dose of study drug.
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 |
|---|---|---|
| ARRY-438162 (MEK162), MEK inhibitor; oralPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule. | Drug | ARRY-438162 (MEK 162) |
Primary outcome
Establish the maximum tolerated dose (MTD) of the study drug.
Time frame: Part 1, one year
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Parts 1, 2 and 3: two years
Characterize the pharmacokinetics (PK) of the study drug and metabolite.
Time frame: Parts 1, 2 and 3: two years
2 secondary outcomes
Assess the efficacy of the study drug in terms of tumor response, duration of response, duration of stable disease, progression-free survival and overall survival.
Time frame: Parts 1, 2 and 3: two years
Assess possible PK/pharmacodynamic (PD) or PK/efficacy and safety correlations.
Time frame: Parts 1, 2 and 3: two years
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 16 Sep 2020.
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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.
Pfizer CT.gov Call Center study director
Pfizer
10 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 ARRY-438162 (MEK162), MEK inhibitor; oral in people with Advanced Solid Tumors and Advanced or Metastatic Biliary Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 10 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 5 inclusion and 10 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Establish the maximum tolerated dose (MTD) of the study drug. (time frame: Part 1, one year). The study lists 3 primary outcomes in all. 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 16 Sep 2020.