A Study of ARRY-334543 in Patients With Advanced Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 5
- 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-334543.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose(s) and schedule(s) 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 it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada 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-334543
Intervention: ARRY-334543, EGFR/ErbB2 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 and Part 2
Establish the maximum tolerated dose (MTD) of study drug.
Time Frame: Part 1
Secondary Outcomes
- Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.(Part 1 and Part 2)
- Assess the efficacy of the study drug in terms of tumor dimension assessment.(Part 1 and Part 2)