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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-520 | Experimental |
| |
| ARRY-520 + G-CSF support | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-520, KSP(Eg5) inhibitor; intravenous | Drug | Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule. |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marlene and Stewart Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States | ||
| Wayne State University, Karmanos Cancer Institute |
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| ID | Term |
|---|---|
| C544550 | filanesib |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous | Drug | Part 1: standard of care; Part 2: standard of care. |
|
| Detroit |
| Michigan |
| 48201 |
| United States |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |