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Preoperative Radiotherapy and E7046 in Rectum Cancer

NCT03152370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-10-04

No results posted yet for this 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

  • Neoadjuvant Therapy in Rectal Cancer

Interventions

DRUG

E7046

oral administration

RADIATION

Long Course Chemoradiotherapy (LCRT)

pelvic radiotherapy

RADIATION

Short Course Radiotherapy (SCRT)

pelvic radiotherapy

DRUG

capecitabine

chemotherapy

DRUG

folinic acid/5-FU/oxaliplatin (mFOLFOX-6)

chemotherapy

Sponsors & Collaborators

  • Adlai Nortye Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2021-08-31
Completion
2021-09-30
FDA Drug
Yes

Countries

  • United States
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152370 on ClinicalTrials.gov