Clinical Trials & Research Studies

A Phase 1 Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma


Brief description of study

PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of PT2385 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2385 Tablets in patients with advanced clear cell renal cell carcinoma (ccRCC). PART 2: The primary objective of this study is to identify the MTD of PT2385 Tablets up to the RP2D, in combination with nivolumab, in patients with advanced ccRCC. PART 3: The primary objective of this study is to identify the MTD of PT2385 Tablets up to the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.

Clinical Study Identifier: NCT02293980

Detailed Study 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 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.

Contact research investigator to learn more about this study by filling out the form below.


To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: A Phase 1 Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma
Included below is some of my health information:
  1. Condition = Renal Cell Carcinoma
I am hoping to hear back from you and discuss details of the study

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