A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer

Study Overview
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Brief Summary
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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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Conditions
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Advanced Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
* Drug: Gemcitabine, nucleoside analogue; intravenous


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria (Part 1): Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine. No more than 3 prior anticancer regimens for advanced disease. Measurable or evaluable, nonmeasurable disease. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Able to take and retain oral medications. Additional criteria exist. Key Exclusion Criteria (Part 1): Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days). Treatment with prior chemotherapy within 21 days of first dose of study drug. Requiring IV alimentation. Pregnancy or lactation. Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. History of being unable to tolerate gemcitabine or any of its components. Additional criteria exist.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-334543 + gemcitabine<br> | Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral<br>* multiple dose, escalating<br>Drug: Gemcitabine, nucleoside analogue; intravenous<br>* multiple dose, single schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |