Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
73

Summary

Conditions
  • ccRCC
  • Clear Cell Renal Cell Carcinoma
  • Kidney Cancer
  • RCC
  • Renal Cell Carcinoma
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention 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

PART 1: This is a Phase 1, multiple-dose, dose-escalation trial of PT2385 Tablets, where patients with advanced ccRCC will be assigned to sequential dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, electrocardiograms (ECGs), and hematology ...

PART 1: This is a Phase 1, multiple-dose, dose-escalation trial of PT2385 Tablets, where patients with advanced ccRCC will be assigned to sequential dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, electrocardiograms (ECGs), and hematology and chemistry laboratory studies, and by recording all adverse events (AEs). Blood will be obtained for analysis of the concentration of PT2385 and to assess biomarkers. PART 2: This is a Phase 1 trial of PT2385 Tablets in combination with nivolumab, where patients with advanced ccRCC will be assigned to dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, ECGs, and hematology and chemistry laboratory studies, and by recording all AEs. Blood will be obtained for analysis of the concentration of PT2385 and to assess biomarkers. PART 3: This is a Phase 1 trial of PT2385 Tablets in combination with cabozantinib tablets, where patients with advanced ccRCC will be assigned to dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, ECGs, and hematology and chemistry laboratory studies, and by recording all AEs. Blood will be obtained for analysis of the concentration of PT2385 and cabozantinb and to assess biomarkers.

Tracking Information

NCT #
NCT02293980
Collaborators
Not Provided
Investigators
Not Provided