ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03922555
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Neurological Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASTX727 — DRUG
    ASTX727 is made up of the 2 study drugs cedazuridine and decitabine. Cedazuridine is believed to work by slowing down how fast decitabine is broken down by the body. Decitabine is believed to work by blocking abnormal cells or cancer cells from growing.

Study Details

this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.

Key Dates

Start date
Jul 12, 2019
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ASTX727 (Cedazuridine + Cytidine Antimetabolite Decitabine)
    -ASTX727 administered orally for 5 or 6 consecutive days every 28d cycle and will de-escalate to 4 consecutive days every 28 d cycle.
  • Experimental: Expansion Cohort
    * Oral ASTX727 will be administered daily for 4, 5 or 6 consecutive days * Surgical resection will take place 12 days (+/- 1 day) after initiation of treatment

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Ugonma Chukwueke, MD
[email protected]
Ugonma Chukwueke, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Ugonma Chukwueke, MD
[email protected]
Ugonma Chukwueke, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Isabel Arrillaga-Romany, MD
[email protected]
617-724-4000
Isabel Arrillaga-Romany, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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