A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis
- Sponsor:
- Sumitomo Dainippon Pharma Oncology, Inc.
- Sponsor Study ID:
- BB1-TP-3654-102
- CTO #:
- 104205
- NCT Number:
- NCT04176198
- Phase:
- I/II
- Protocol Type:
- Treatment
- Age Group:
- Adults
- Disease Sites:
- Other Hematopoietic
- Study Objectives:
- To identify the recommended Phase 2 dose (RP2D) of nuvisertib monotherapy. To determine the overall safety of nuvisertib monotherapy [Note: This objective is secondary in Phase 1]. To assess any preliminary clinical activity of nuvisertib monotherapy [Note: This objective is secondary in Phase 1].
- eConsent:
- Not available
- Study Documents:
-
Open Study Documents
(MUSC NetID required for document access)
For more information about this trial please contact the study team:
-
Medical University of South Carolina
- Principal Investigator, Coltoff, Alexander, at coltoff@musc.edu .
- Study Coordinator, Baker, Hana, at bakerhan@musc.edu .
Trial opened at the following institutions:
Medical University of South Carolina