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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 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. The trial reports 5 study locations across 3 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03152370
The ClinicalTrials.gov registry entry for NCT03152370 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adlai Nortye Biopharma Co., which has 6 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.
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