drugset / Trial / NCT02197676
A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response
Phase 2
Completed
56 enrolled
Groupe Francophone des Myelodysplasies
Astex Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response.
Timeline
- Start
- 2014-08-04
- Primary completion
- 2016-02-06
- Completion
- 2018-04-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guadecitabine | Oligonucleotide (other) | 30 mg/m2 | Subcutaneous |
| Subject | Guadecitabine | Oligonucleotide (other) | 45 mg/m2 | Subcutaneous |
| Subject | Guadecitabine | Oligonucleotide (other) | 60 mg/m2 | Subcutaneous |