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

March 29, 2024 updated by: Asahi Kasei Pharma Corporation

Phase 2 Clinical Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer: a Multicenter Randomized Placebo-controlled Double-blind Study to Investigate the Efficacy and Safety of ART-123

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan
    • Tokyo
      • Nerima, Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Diagnosed with stage II / III colon cancer
  • Deemed to have undergone curative A (Cur A) surgery
  • Planning to undergo postoperative adjuvant chemotherapy

Main Exclusion Criteria:

  • Have a history of hypersensitivity to any of the ingredients in thrombomodulin alfa (recombinant)
  • Have any treatment history of systemic chemotherapy (including any drug in the clinical trial stage) or radiotherapy
  • With active double cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo infusion once daily on days 1-3 in each cycle
Experimental: ART-123 (3-day ART)
Drug: ART-123 (3-day ART)
ART-123 380 U/kg infusion once daily on days 1-3 in each cycle
Experimental: ART-123 (1-day ART)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment
Time Frame: 42 days after the start of cycle 12 (each cycle is 2 weeks).
NCI-CTCAE was used for investigator-reported outcomes of peripheral sensory neuropathy; it was assessed every day from day 1 to day 3 of each cycle and on days 15 (the day after 14 days have elapsed from the date of administration) of Cycle 12 and 43 (the day after 42 days have elapsed from the date of administration of Cycle 12) of cycle 12 as follow-up assessment. Once grade 2 or higher neuropathy was observed in a certain participant, that participant was categorized as grade 2 or higher even if the grade returned to 1 or lower in subsequent cycles. Participants who discontinued the study or whose evaluation data were missing without reaching grade 2 or higher neuropathy were analyzed as no grade 2 or higher neuropathy. No primary endpoint was specified due to the exploratory nature of the study.
42 days after the start of cycle 12 (each cycle is 2 weeks).
Least-squares (LS) Means of Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) Version 4.0 Score at Cycle 12
Time Frame: At baseline, at each cycle (up to cycle 12 with each cycle of 2 weeks), and follow-up assessment.
Participant-reported outcomes were evaluated using the FACT/GOG-Ntx-12 version 4.0, which measured the severity and impact of symptoms of neuropathy over the past 7 days. Scores range from 0 to 48, with lower scores indicating more severe neurotoxicity. Participants completed paper questionnaires on days 1 and 8 of each cycle, on day 15 (the day after 14 days have elapsed from the date of administration) of cycle 12 and day 43 (the day after 42 days have elapsed from the date of administration) of cycle 12 as follow-up assessment. LS means were calculated from the mixed effect model for repeated measures (MMRM). Analysis included the fixed, categorical effects of study treatment, analysis visit, and study treatment-by-visit interaction. If multiple measurements occurred within the same visit, the measurement with the worst value was used. No primary endpoint was specified due to the exploratory nature of the study.
At baseline, at each cycle (up to cycle 12 with each cycle of 2 weeks), and follow-up assessment.
The Discontinuation Rate of Oxaliplatin Due to Oxaliplatin-Induced Peripheral Neuropathy (OIPN)
Time Frame: Cycle 12（each cycle is 2 weeks）
The number of people who discontinued oxaliplatin because of OIPN was counted and the percentage of the total was calculated. No primary endpoint was specified due to the exploratory nature of the study.
Cycle 12（each cycle is 2 weeks）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asahi Kasei Pharma Corporation

Investigators

  • Study Chair: Asahi Kasei Pharma Corporation, Asahi Kasei Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

May 28, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimated)

June 8, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-123-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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