Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

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-3654 in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetic (PK) profile of orally administered TP-3654 To observe patients for any evidence of an...

Primary Objective: • To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-3654 in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetic (PK) profile of orally administered TP-3654 To observe patients for any evidence of antitumor activity of TP-3654 by objective radiographic assessment To study the pharmacodynamic effects of TP-3654 therapy To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-3654

Tracking Information

NCT #
NCT03715504
Collaborators
Not Provided
Investigators
Study Director: Sumitomo Dainippon Pharma Oncology, MD Sumitomo Dainippon Pharma Oncology, Inc