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A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine. The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine 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 24 patients from the US will be enrolled in Part 1 (Completed). In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
Details
| Lead sponsor | Array BioPharma |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2009-03 |
| Completion | 2011-02 |
Conditions
- Advanced Cancer
- Pancreatic Cancer
Interventions
- ARRY-334543, EGFR/ErbB2 inhibitor; oral
- Gemcitabine, nucleoside analogue; intravenous
Primary outcomes
- Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. — Part 1
- Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. — Part 1
- Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. — Part 1
- Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks. — Part 2
Countries
United States