Clinical trial · Interventional
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
A Phase II Study of MGCD0103 (MG-0103) in Patients With Acute Myelogenous Leukemia/High Risk MDS Who Are Elderly and Have Previously Untreated Disease or Who Are Adult and Have Relapsed/Refractory Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Clinical Development Program for MGCD0103 is being re-evaluated
Summary
Brief summary (as posted)
In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelogenous Leukemia, Acute | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGCD0103 | Drug | Mocetinostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- 1
- description
- Elderly (≥65 years) untreated arm
- type
- EXPERIMENTAL
- label
- 2
- description
- Relapsed/Refractory Arm
- interventionNames
- Drug: MGCD0103
Primary outcomes (2)
- measure
- Safety and tolerability
- timeFrame
- 1 year (anticipated
- measure
- Response rate
- timeFrame
- 1 year (anticipated)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of AML or high risk MDS. * Elderly cohort (70 years of age or more): no prior chemotherapy treatment for AML/high risk MDS and not currently candidates for intensive chemotherapy. * Relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment. * ECOG performance status of 0 or 1. * Total bilirubin \< 1.5 x upper limit of normal (ULN). * AST/SGOT and ALT/SGPT \< 2.5 x ULN. * Serum creatinine \< 1.5 x ULN. * Patients must read, understand, and sign a written informed consent form (ICF). * Women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment. Exclusion Criteria: * Pregnant or lactating women. * Patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever \> 38.5C (not due to tumor fever) on the day of scheduled dosing. * Patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results. * Patients treated with an investigational drug within 30 days prior to study initiation. * Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103. * Known HIV or active hepatitis B or C. * Any condition that may affect the patient's ability to sign the ICF and undergo study procedures. * Any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
References
Publications (0)
Data not yet available