Advanced Solid Tumor
Conditions
Keywords
MEK, Advanced solid tumor
Brief 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.
Interventions
DRUGMEK162
MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).
Sponsors
Array Biopharma, now a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose limiting toxicities | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events, changes in laboratory values | 4 months | Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment. |
| Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite. | 2 months | 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. |
| Tumor responses according to RECIST 1.1 | 4 months | Tumor responses will be measured according to RECIST 1.1 |
| Levels of p-ERK in tumor and skin | 4 months | Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured. |
Countries
Japan
Outcome results
None listed