drugset / Trial / NCT02717884
Study of Sensitization of Non-M3 AML Blasts to ATRA by Epigenetic Treatment With Tranylcypromine (TCP)
NaSingle-groupOpen-labelTreatment
Summary
The objective of the phase I part of the trial is the determination of the maximum tolerated dose (MTD) of TCP (Tranylcypromine) in combination with fixed-dose ATRA (all-trans-retinoic acid) and with fixed-dose AraC (Cytarabine) and to derive the recommended phase II dose (RP2D) in patients with non-APL AML or MDS for whom no standard treatment is available or who failed azanucleoside treatment. The objective of the phase II part of the trial is a first evaluation of the efficacy of TCP at the RP2D in combination with fixed-dose ATRA and with fixed-dose AraC as basis for further investigations of TCP
Timeline
- Start
- 2015-05
- Primary completion
- 2020-12
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranylcypromine | Small molecule | 10 mg | Oral |
| Subject | Tranylcypromine | Small molecule | 20 mg | Oral |
| Subject | Tranylcypromine | Small molecule | 40 mg | Oral |
| Subject | Tranylcypromine | Small molecule | 60 mg | Oral |
| Subject | Tranylcypromine | Small molecule | 80 mg | Oral |
| Background | Cytarabine | Small molecule | 40 mg | Subcutaneous |
| Background | Tretinoin | Small molecule | 45 mg/m2 | — |