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Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer

NCT02792842 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-04-04

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.

Conditions

  • Postoperative Stage II/III Colon Cancer

Interventions

DRUG

ART-123 (3-day ART)

ART-123 380 U/kg infusion once daily on days 1-3 in each cycle

DRUG

ART-123 (1-day ART)

ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle

DRUG

Placebo

Placebo infusion once daily on days 1-3 in each cycle

Sponsors & Collaborators

  • Asahi Kasei Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Asahi Kasei Pharma Corporation · Asahi Kasei Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Japan

Study Locations

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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 NCT02792842 on ClinicalTrials.gov