Advanced Solid TumorPhase 1NCT01469130
A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
A Phase 1 study testing MEK162 in people with Advanced Solid Tumor, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 2 sites in Japan.
Trial summary
In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- MEK162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesJapan
- Study dates
- Nov 2011to 1 Feb 2018
- 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
- Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit.
- Availability of a representative formalin fixed paraffin embedded tumor tissue sample.
- At least one measurable or non-measurable lesion
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Good organ (hepatic, kidney, BM) function at screening/baseline visit.
Who cannot join
- Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
- Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
- Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Pfizer Investigative Site
Nagoya, Aichi-ken, 466-8560
Pfizer Investigative Site
Yufu, Oita Prefecture, 879-5593
About this study
In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.
- Conditions
- Advanced Solid Tumor
- Being tested
- MEK162
- Keywords
- MEK, Advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEK162Drug
MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).
| Study group | Role | What they receive |
|---|---|---|
| MEK162 | Experimental | MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies.
The prescribed BID doses should be taken 12 ± 2 hrs apart. Receives: Drug: MEK162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose limiting toxicities
Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE).
Measured: 4 weeks
Secondary outcomes (4)
Incidence and severity of adverse events and serious adverse events, changes in laboratory values
Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
Measured: 4 months
Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.
Plasma concentration of MEK162 and active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite will be measured with serial plasma samples during treatment for first 2 months.
Measured: 2 months
Tumor responses according to RECIST 1.1
Tumor responses will be measured according to RECIST 1.1
Measured: 4 months
Levels of p-ERK in tumor and skin
Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2014
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 21 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
- NCT01469130
- Sponsor's protocol ID
- CMEK162X1101
- Status last verified
- Sep 2020
- First submitted
- 8 Nov 2011
- Last updated
- 5 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01469130
- Acronym / sponsor ID
- CMEK162X1101
- Conditions
- Advanced Solid Tumor
- Keywords
- MEK, Advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 10 Nov 2011 (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.
In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEK162 | Experimental | Drug: MEK162MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies. The prescribed BID doses should be taken 12 ± 2 hrs apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit.
- Availability of a representative formalin fixed paraffin embedded tumor tissue sample.
- At least one measurable or non-measurable lesion
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Key exclusion criteria (4 listed)
- Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
- Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
- Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| MEK162MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets). | Drug | MEK162 |
Primary outcome
Incidence of Dose limiting toxicities
Time frame: 4 weeks
Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE).
4 secondary outcomes
Incidence and severity of adverse events and serious adverse events, changes in laboratory values
Time frame: 4 months
Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.
Time frame: 2 months
Tumor responses according to RECIST 1.1
Time frame: 4 months
Levels of p-ERK in tumor and skin
Time frame: 4 months
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 5 Oct 2020.
Related trials for Advanced Solid Tumor
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Active, not recruitingPhase 2
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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
2 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 MEK162 in people with Advanced Solid Tumor, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 2 sites 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 4 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 5 Oct 2020. 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. 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?
Incidence of Dose limiting toxicities (time frame: 4 weeks). 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 5 Oct 2020.