A Study of ARRY-520 in Patients With Advanced Cancer

Study Overview
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Brief Summary
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This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520. This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed). In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
* Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Histological or cytological evidence of malignancy. Advanced solid tumors that have recurred or progressed following standard therapy(ies). Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Adequate hematology counts and serum chemistry values. Additional criteria exist. Key Exclusion Criteria: Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug. Major surgery within 28 days prior to the first dose of study drug. Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to <5% of the bone marrow). Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B. 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-520<br> | Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous<br>* Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.<br>|
| Experimental: ARRY-520 + G-CSF support<br> | Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous<br>* Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.<br>Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous<br>* Part 1: standard of care; Part 2: standard of care.<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, with and without G-CSF. |  | Part 1 | 
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. |  | Part 1 and Part 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the pharmacokinetics of the study drug. |  | Part 1 and Part 2 | 
| Assess the efficacy of the study drug in terms of tumor response. |  | Part 1 and Part 2 |