Advanced Solid Tumors
Conditions
Brief summary
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).
Interventions
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Part 1: standard of care; Part 2: standard of care.
Sponsors
Array Biopharma, now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed