Status:
ACTIVE_NOT_RECRUITING
A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
Lead Sponsor:
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
ccRCC
RCC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of MK-3795, formerly called PT2385 and/or the recommended Phase 2 dose (RP2D) of MK-3795 in patients with ad...
Detailed Description
PART 1: This is a Phase 1, multiple-dose, dose-escalation trial of MK-3795, where patients with advanced ccRCC will be assigned to sequential dose cohorts. Patient safety will be monitored with freque...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- PART 1
- Has locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) and has progressed during treatment with at least one prior therapeutic regimen
- Has a life expectancy of ≥ 3 months
- Has adequate organ function
- Able to swallow oral medications
- PART 2 - In addition to PART 1
- Received no more than three prior systemic treatment regimens in the advanced or metastatic setting
- Must have received at least one but not more than two prior anti-angiogenic therapy regimens
- PART 3 - In addition to PART 1
- Must have received at least one vascular endothelial growth factor receptor (VEGFR) targeting tyrosine kinase inhibitor
- Exclusion Criteria
- PART 1
- 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 human immunodeficiency virus (HIV) infection
- Has an active infection requiring systemic treatment
- Is participating in another therapeutic clinical trial
- PART 2 - In addition to PART 1
- Has received prior immunotherapy
- Has any active or recent history of a known or suspected autoimmune disease
- PART 3 - In addition to PART 1
- Has gastrointestinal (GI) disorders
- Has any history of congenital long QT syndrome
Exclusion
Key Trial Info
Start Date :
November 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02293980
Start Date
November 25 2014
End Date
November 30 2026
Last Update
June 17 2024
Active Locations (25)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
3
Yale School of Medicine
New Haven, Connecticut, United States, 06510
4
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136