A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
Overview
- Phase
- Phase 1
- Intervention
- ARRY-334543, EGFR/ErbB2 inhibitor; oral
- Conditions
- Advanced Cancer
- Sponsor
- Array BioPharma
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ARRY-334543 + gemcitabine
Intervention: ARRY-334543, EGFR/ErbB2 inhibitor; oral
ARRY-334543 + gemcitabine
Intervention: Gemcitabine, nucleoside analogue; intravenous
Outcomes
Primary Outcomes
Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.
Time Frame: Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame: Part 1
Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.
Time Frame: Part 1
Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.
Time Frame: Part 2
Secondary Outcomes
- Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.(Part 1)
- Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.(Part 2)