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NCT03516708 · ClinicalTrials.gov registry record · Phase 1
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
A Phase 1 study of Rectal Cancer, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 4
- Study locations
NCT03516708: Recruiting Phase 1 study of Rectal Cancer, sponsored by Washington University School of Medicine.
NCT03516708 is a Phase 1 study of Rectal Cancer that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 49 participants, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03516708, a Phase 1 study of Rectal Cancer, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this research study is to evaluate epacadostat when given with routine radiation therapy and chemotherapy (capecitabine and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the tumor.
Primary Outcome
The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the maximally administered dose at which 0 or 1 of a cohort of 3 to 6 patients experienced a dose-limiting toxicity (DLT) during first 2 cycles.
Conditions Studied
Interventions
- DRUG Epacadostat
- RADIATION Short-course radiation therapy
- DRUG CAPOX chemotherapy
- DRUG FOLFOX chemotherapy
Study Locations (4)
California
- University of California Irvine - Chao Family Comprehensive Cancer Center - Orange
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- Henry Ford Cancer Institute - Detroit
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2020-01-06 |
| Est. Completion | 2030-08-12 |
| Phase | Phase 1 |
What NCT03516708 shows while recruiting
NCT03516708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Epacadostat is the first listed.
NCT03516708 reports a single indexed study location in California, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT03516708 about?
NCT03516708 is a clinical study titled "Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer". The purpose of this research study is to evaluate epacadostat when given with routine radiation therapy and chemotherapy (capecitabine and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the tumor.
What is the current status of trial NCT03516708?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2020-01-06. Estimated completion is 2030-08-12.
What conditions does trial NCT03516708 study?
This clinical trial studies the following conditions: Rectal Cancer.
What interventions are being tested in trial NCT03516708?
The interventions under investigation include: Epacadostat (DRUG), Short-course radiation therapy (RADIATION), CAPOX chemotherapy (DRUG), FOLFOX chemotherapy (DRUG).
Who is sponsoring clinical trial NCT03516708?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03516708 being conducted?
This trial has 4 study locations across California, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03516708's enrollment target sits among peer trials
49 41st of 70 higher than 30 of 70 other Rectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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