A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma
Conditions
ccRCC - RCC - Kidney Cancer - Clear Cell Renal Cell Carcinoma - Renal Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Renal Cell
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PT2385 Tablets
Type: Drug
Overall Status
Recruiting
Summary
The primary objective of this study is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of PT2385 Tablets in patients with advanced clear cell renal cell carcinoma (ccRCC).
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria

- Has locally advanced or metastatic ccRCC and has progressed during treatment with at least 1 prior therapeutic regimen

- Is of age ≥ 18 years

- Has a life expectancy of ≥ 3 months

- Has adequate organ function

- If a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration

- Able to swallow oral medications

Exclusion Criteria

- Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression

- Has failed to recover from the reversible effects of prior anticancer therapy

- Has uncontrolled or poorly controlled hypertension

- Is receiving warfarin anticoagulant therapy or expected to require warfarin

- Has had any major cardiovascular event within 6 months prior to study drug administration

- Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results

- Has had major surgery within 4 weeks before first study drug administration

- Has known HIV

- Has an active infection requiring systemic treatment

- Is participating in another therapeutic clinical trial
Locations
Cedars-Sinai Medical Center
Los Angeles, California, United States
Status: Recruiting
Contact: Amy Oppenheim - 310-423-3713
University of Colorado Cancer Center
Aurora, Colorado, United States
Status: Recruiting
Contact: Moses Ongalo - 720-848-0735
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Toni Choueiri, MD - 617-632-5456
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Kimberly Benjamin, RN - 405-271-8778
Tennessee Oncology
Nashville, Tennessee, United States
Status: Recruiting
Contact: - 877-691-7274
UT Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Contact: Joyce Bolluyt, RN - 214-648-7007
Start Date
November 2014
Completion Date
December 2016
Sponsors
Peloton Therapeutics, Inc.
Source
Peloton Therapeutics, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page