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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1, Multiple-Dose, Dose-Escalation Trial of PT2385 Tablets, a HIF-2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma

Brief Summary:

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.

Detailed Summary:

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.

Sponsor: Peloton Therapeutics, Inc.

Current Primary Outcome: maximum tolerated dose (MTD) [ Time Frame: PART 1: 3 Weeks, PART 2: 4 Weeks, PART 3: 4 Weeks ]

Original Primary Outcome: maximum tolerated dose (MTD) [ Time Frame: 3 Weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Peloton Therapeutics, Inc.

Dates:
Date Received: November 14, 2014
Date Started: November 2014
Date Completion: September 2018
Last Updated: March 28, 2017
Last Verified: March 2017