Phase 1Completed
BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors
A Phase 1a/b Non-randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously to Patients With Solid Tumors
- Sponsor
- BPGbio (Industry)
- Enrolment
- 97 enrolled
- Conditions
- Metastatic Cancer; Cancer; Solid Tumor
- Interventions
- BP31510 monotherapy; BP31510 in combination with chemotherapy
- Ages
- adults, older adults
- Registry
- NCT01957735
From the registry
This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors.
Primary outcomes
- Determine Maximum Tolerated Dose (MTD) of BP31510