A Study of ARRY-142886 in Patients With Advanced Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 57
- Locations
- 3
- Primary Endpoint
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Study Overview
Brief Summary
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-142886.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 25 patients from the US will be enrolled in Part 1 (Completed).
In the second part of the study, patients 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 the study drug causes and what effectiveness the study drug has, if any, in treating the cancer. Approximately 35 patients from the US will be enrolled in Part 2 (Completed).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ARRY-142886
Intervention: ARRY-142886, MEK inhibitor; oral (Drug)
Outcomes
Primary Outcomes
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time Frame: Part 1
Establish the maximum tolerated dose (MTD) of study drug.
Time Frame: Part 1
Assess the biological activity of the study drug in tumors in terms of inhibition of extracellular signal-regulated kinase (ERK) phosphorylation.
Time Frame: Part 2
Secondary Outcomes
- Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.(Part 1 and Part 2)
- Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.(Part 1 and Part 2)
- Assess the efficacy of the study drug in terms of tumor dimension assessment.(Part 1 and Part 2)
- Confirm the safety of the study drug at the MTD as determined by adverse events, clinical laboratory tests, vital signs and electrocardiograms.(Part 2)