A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer
NCT00710736 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2020-10-06
Summary
This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US and Canada will be enrolled in this study.
Conditions
Interventions
- DRUG
-
ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
- DRUG
-
Capecitabine, 5-fluorouracil prodrug; oral
multiple dose, single schedule
Sponsors & Collaborators
-
Array Biopharma, now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- United States
- Canada
Study Locations
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