drugset / Trial / NCT03196947
Safety and Pharmacokinetics of Rising Doses of APO010 in Relapsed/Refractory Multiple Myeloma Patients Selected by DRP
Phase 1/2
Terminated
1 enrolled
Allarity Therapeutics
Medical Prognosis Institute A/S · collabSmerud Medical Research International AS · collab
NaSingle-groupOpen-labelTreatment
Summary
Multicentre, open label, uncontrolled, phase I pharmacokinetic study, to determine the Maximum Tolerated Dose (MTD) of APO010 administered intravenously on D1, D8 and D15 followed by a one-week drug rest, in patients with multiple myeloma for who have relapsed or are refractory to 2 (in high-risk patients 1) or more different prior therapies and who have Drug Response Predictor (DRP) for APO010 indicating a higher likelihood for response to APO010. The study will contain an extension phase where the recommended Dose will be tested on additional patients.
Timeline
- Start
- 2017-06-13
- Primary completion
- 2020-01-16
- Completion
- 2020-01-16
Outcome
Outcome not reported
Stopped: “The study was terminated early due to sponsors decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APO010 | Protein / enzyme biologic | — | Intravenous |