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This is an open-label, single arm, dose escalation study in patients with advanced cancers.
This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYC065 - 4 hour infusion (Part 1 completed) | Experimental | CYC065 will be administered by 4 -hour infusion every 3 weeks. |
|
| CYC065 - 1 hour infusion (Part 2 - ongoing) | Experimental | CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks |
|
| CYC065 - Oral (Part 3 - ongoing) | Experimental | CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYC065 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experience dose-limiting toxicities | cycle 1(each cycle is 21 -28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations | cycle 1(each cycle is 21 -28 days) | |
| Half-life of CYC065 | cycle 1(each cycle is 21 -28 days) | |
| changes in certain protein levels in peripheral white blood cells by western blots |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Shapiro, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000621593 | CYC065 |
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| cycle 1(each cycle is 21 -28 days) |