Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03875287

Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Solid Tumor

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed.
  • Patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition.
  • ECOG performance status <1
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must have measurable disease
  • Ability to swallow oral medications

Exclusion criteria

  • Participants who have had chemotherapy or radiotherapy within 3 weeks
  • Participants may not be receiving any other investigational agents.
  • Active hepatitis B or hepatitis C infection.
  • Active or untreated gastric or duodenal ulcer
  • Symptomatic bowel obstruction within 3 months prior to screening visit.
  • Symptomatic ascites in the last 4 weeks

Other protocol defined inclusion/exclusion criteria may apply.

Treatment and study plan

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

Other names: Dacogen

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

Primary outcomes

  1. 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)

  2. 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).

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Astex Pharmaceuticals, Inc.
  • Stand Up To Cancer

Registry information

Official study title

A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Mar 14, 2019
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.