Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03875287|
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Decitabine Drug: Cedazuridine||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Decitabine and Cedazuridine
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.
Level -1 5mg daily days 1-10
Level 1 5mg daily days 1-14
Level 2 10mg daily days 1-14
Level 3 15mg daily days 1-14
Other Name: Dacogen
Level -1 100g daily days 1-10
Level 1 100mg daily days 1-14
Level 2 100mg daily days 1-14
Level 3 100mg daily days 1-14
- Safety and tolerability of combination cedazuridine with decitabine as assessed by number of participants who experience adverse events [ Time Frame: up to 2 years ]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)
- Maximum Tolerated Dose (MTD) as determined by number of participants with of dose limiting toxicities (DLT) [ Time Frame: up to 2 years ]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).
- Pharmacokinetics of ASTX727 in solid tumor patients as measured by total exposure [ Time Frame: Day 2 ]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)
- Pharmacokinetics of ASTX727 in solid tumor patients as measured by maximum concentration (Cmax) [ Time Frame: Day 2 ]Cmax (mmol/L) is defined as the maximum concentration of ASTX727 in blood.
- Pharmacokinetics of ASTX727 in solid tumor patients as measured by time to maximum concentration (Tmax) [ Time Frame: Day 2 ]Tmax (minutes) is defined as the time to reach maximum concentration of ASTX727 in blood.
- Objective response rate (ORR) in solid tumor patients who are treated with ASTX727 [ Time Frame: up to 2 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875287
|Contact: Angela Scardina, RNfirstname.lastname@example.org|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Nilofer Azad, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|