Study of Monzosertib In Patients With R/R AML Or High-Risk Myelodysplastic Syndrome

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07780565
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome

Eligibility Criteria

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

Interventions

  • Monzosertib — DRUG
    Give by mouth
  • Posaconazole — DRUG
    Given by mouth
  • Isavuconazole — DRUG
    Given by mouth

Study Details

The goal of this clinical research study is to find the recommended dose of monzosertib in patients with relapsed/refractory AML and high-risk MDS. The safety and effects of monzosertib will also be studied.

Key Dates

First listed
Aug 21, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Aug 30, 2029
Completion
Aug 30, 2031

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Phase 1b ESC Arm 1 Treatment - Monzosertib with No Azoles
    Participants may initiate treatment in the inpatient environment, at the discretion of the treating physician.
  • Experimental: Arm 2: Phase 1b ESC Arm 2 Treatment - Monzosertib with Posaconazole
    Participants may initiate treatment in the inpatient environment, at the discretion of the treating physician.
  • Experimental: Arm 3: Phase 1b ESC Arm 3 Treatment - Monzosertib with Isavuconazole
    Participants may initiate treatment in the inpatient environment, at the discretion of the treating physician.

Primary Outcome Measure

Safety and Adverse Events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030
Abhishek Maiti, MBBS
[email protected]
713-745-3228
Abhishek Maiti, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
UT MD Anderson Cancer Center· Houston, TX

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