First-in-human Study of Oral TP-0184 in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Advanced Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objective: • To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0184 administered once weekly for 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP...
Primary Objective: • To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0184 administered once weekly for 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0184 To observe patients for any evidence of antitumor activity of TP-0184 by objective radiographic assessment To study the pharmacodynamics of TP-0184 therapy To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0184
Tracking Information
- NCT #
- NCT03429218
- Collaborators
- Not Provided
- Investigators
- Study Director: Greg Pennock, MD Sumitomo Dainippon Pharma Oncology, Inc
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