Clinical trial · Interventional
A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes
A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose In Patients With Leukemia Or Myelodysplastic Syndromes
NCT00324129CI-TRIAL-00016547completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGCD0103 | Drug | Mocetinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: MGCD0103
Primary outcomes (2)
- measure
- Safety and tolerability
- timeFrame
- 1 year (anticipated)
- measure
- Pharmacokinetics
- timeFrame
- 1 year (anticipated)
Secondary outcomes (3)
- measure
- Clinical Response
- timeFrame
- 1 year (anticipated)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a diagnosis of one of the following: * relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy * relapsed or refractory Myelodysplastic Syndromes * previously untreated AML or Myelodysplastic Syndromes in patients \> 60 years of age who refused or are not candidates for induction chemotherapy * Patients with relapsed or refractory CML that has failed to respond to Imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists * ECOG performance status of 0, 1, or 2 * Age ≥ 18 years * Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry Exclusion Criteria: * Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia * Pregnant or lactating women * Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the study and for 90 days following the last dose of study medication * Patients with known meningeal metastasis(es) * Patients with active or uncontrolled infections, or with a fever \>38.5 C * Patients with serious illnesses, medical conditions, or other medical history, which would be likely to interfere with a patient's participation in the study * Patients who have been treated with any investigational drug or anti-cancer therapy within 30 days of study start.
References
Publications (0)
Data not yet available
No reference posted for this study.