drugset / Trial / NCT04067518
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Phase 2
Completed
28 enrolled
Servier
ADIR, a Servier Group company · collabKyowa Kirin, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.
Timeline
- Start
- 2019-10-17
- Primary completion
- 2021-02-12
- Completion
- 2022-02-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegaspargase | Protein / enzyme biologic | 82.5 iu/kg | Intravenous |
| Subject | Pegaspargase | Protein / enzyme biologic | 2500 iu | Intravenous |