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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00182038 | Other Identifier | JHM IRB | |
| ASTX727 | Other Identifier | Astex Pharmaceuticals |
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| Name | Class |
|---|---|
| Astex Pharmaceuticals, Inc. | INDUSTRY |
| Stand Up To Cancer | OTHER |
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This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 35 patients total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine and Cedazuridine | Experimental | Treatment will be administered on an outpatient basis. Cycle length is 28 days. The dose of cedazuridine is fixed at 100mg and the dose and duration of decitabine will vary depending on when a patient enters the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | DOSING REGIMEN(S): Level -1 10mg daily days 1-4 Level 1 10mg daily days 1-5 Level 2 15mg daily days 1-5 Level 3 20mg daily days 1-5 Level 4 25 mg daily days 1-5 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of combination cedazuridine with decitabine as assessed by number of participants who experience adverse events | Number of participants who have experienced grade 3 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) | up to 2 years |
| Maximum Tolerated Dose (MTD) as determined by number of participants with of dose limiting toxicities (DLT) | Maximum tolerated dose will be determined by the maximum dose at which the least number of participants experience dose-limiting toxicity. The dose limiting toxicity is defined using the Common Terminology Criteria for Adverse Events (CTCAE). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ASTX727 in solid tumor patients as measured by total exposure | Total exposure will be calculated as area under the plasma concentration-time curve (AUC) by using non-compartmental methods (Winonlin, version 5.3 or newer) and/or compartmental modeling (Adapt II, release 4.0) | Day 2 |
| Pharmacokinetics of ASTX727 in solid tumor patients as measured by maximum concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Nilofer Azad, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| Cedazuridine | Drug | DOSING REGIMEN(S): Level -1 100mg daily days 1-4 Level 1 100mg daily days 1-5 Level 2 100mg daily days 1-5 Level 3 100mg daily days 1-5 Level 4 100mg daily days 1-5 |
|
Cmax (mmol/L) is defined as the maximum concentration of ASTX727 in blood. |
| Day 2 |
| Pharmacokinetics of ASTX727 in solid tumor patients as measured by time to maximum concentration (Tmax) | Tmax (minutes) is defined as the time to reach maximum concentration of ASTX727 in blood. | Day 2 |
| Objective response rate (ORR) in solid tumor patients who are treated with ASTX727 | Proportion of participants who had measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST 1.1: Complete response (CR)= disappearance of all target lesions, Partial response (PR)= at least 30% decrease in sum of diameters of target lesions | up to 2 years |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| ID | Term |
|---|---|
| D000077209 | Decitabine |
| C000633944 | cedazuridine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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