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NCT03152370 · ClinicalTrials.gov registry record · Phase 1
Preoperative Radiotherapy and E7046 in Rectum Cancer
A Phase 1 study of Neoadjuvant Therapy in Rectal Cancer, sponsored by Adlai Nortye Biopharma Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 5
- Study locations
NCT03152370: Completed Phase 1 study of Neoadjuvant Therapy in Rectal Cancer, sponsored by Adlai Nortye Biopharma Co..
NCT03152370 is a Phase 1 study of Neoadjuvant Therapy in Rectal Cancer that has completed, run by Adlai Nortye Biopharma Co.. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03152370, a Phase 1 study of Neoadjuvant Therapy in Rectal Cancer, has completed, sponsored by Adlai Nortye Biopharma Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of the combination in the expansion part at RP2D.
Primary Outcome
The MTD is defined as one dose level below the dose level where ≥2 of 6 participants experience a dose-limiting toxicity (DLT; study drug-related toxicity) (ie, ≥33% of participants with a DLT at that dose level).
Conditions Studied
Interventions
- DRUG capecitabine
- DRUG E7046
- RADIATION Long Course Chemoradiotherapy (LCRT)
- RADIATION Short Course Radiotherapy (SCRT)
- DRUG folinic acid/5-FU/oxaliplatin (mFOLFOX-6)
Study Locations (5)
Other
- Marie-Skodowska Curie Cancer Centre - Warsaw
- The Christie - Manchester
- Mount Vernon Hospital - Northwood
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Weill Cornell - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 1 |
What the finished NCT03152370 record still lists
NCT03152370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Neoadjuvant Therapy in Rectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which capecitabine is the first listed.
NCT03152370 lists 5 locations in 3 states (Other, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT03152370 about?
NCT03152370 is a clinical study titled "Preoperative Radiotherapy and E7046 in Rectum Cancer". This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerabilit...
What is the current status of trial NCT03152370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2017-05-17. Estimated completion is 2021-09-30.
What conditions does trial NCT03152370 study?
This clinical trial studies the following conditions: Neoadjuvant Therapy in Rectal Cancer.
What interventions are being tested in trial NCT03152370?
The interventions under investigation include: capecitabine (DRUG), E7046 (DRUG), Long Course Chemoradiotherapy (LCRT) (RADIATION), Short Course Radiotherapy (SCRT) (RADIATION), folinic acid/5-FU/oxaliplatin (mFOLFOX-6) (DRUG).
Who is sponsoring clinical trial NCT03152370?
This trial is sponsored by Adlai Nortye Biopharma Co., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03152370 being conducted?
This trial has 5 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03152370's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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