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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

Primary Purpose

Postoperative Stage II/III Colon Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ART-123 (3-day ART)
ART-123 (1-day ART)
Placebo
Sponsored by
Asahi Kasei Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Stage II/III Colon Cancer

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ART-123 (3-day ART)

ART-123 (1-day ART)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The cumulative incidences of NCI-CTCAE grade 2 or higher peripheral sensory neuropathy
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 and 43 of cycle 12. 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.
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
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 and on days 15 and 43 of cycle 12, with follow-up assessment on the last day (day 43). LS means were calculated from the mixed effect model for repeated measures (MMRM). No primary endpoint was specified due to the exploratory nature of the study.
The discontinuation rate of oxaliplatin due to OIPN
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.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2016
Last Updated
April 30, 2021
Sponsor
Asahi Kasei Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02792842
Brief Title
Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Stage II/III Colon Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART-123 (3-day ART)
Arm Type
Experimental
Arm Title
ART-123 (1-day ART)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ART-123 (3-day ART)
Intervention Description
ART-123 380 U/kg infusion once daily on days 1-3 in each cycle
Intervention Type
Drug
Intervention Name(s)
ART-123 (1-day ART)
Intervention Description
ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo infusion once daily on days 1-3 in each cycle
Primary Outcome Measure Information:
Title
The cumulative incidences of NCI-CTCAE grade 2 or higher peripheral sensory neuropathy
Description
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 and 43 of cycle 12. 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.
Time Frame
Cycle 12（each cycle is 2 weeks）
Title
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
Description
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 and on days 15 and 43 of cycle 12, with follow-up assessment on the last day (day 43). LS means were calculated from the mixed effect model for repeated measures (MMRM). No primary endpoint was specified due to the exploratory nature of the study.
Time Frame
Cycle 12（each cycle is 2 weeks）
Title
The discontinuation rate of oxaliplatin due to OIPN
Description
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.
Time Frame
Cycle 12（each cycle is 2 weeks）

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asahi Kasei Pharma Corporation
Organizational Affiliation
Asahi Kasei Pharma Corporation
Official's Role
Study Chair
Facility Information:
City
Kobe
State/Province
Hyogo
Country
Japan
City
Nerima
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32965539
Citation
Kotaka M, Saito Y, Kato T, Satake H, Makiyama A, Tsuji Y, Shinozaki K, Fujiwara T, Mizushima T, Harihara Y, Nagata N, Kurihara N, Ando M, Kusakawa G, Sakai T, Uchida Y, Takamoto M, Kimoto S, Hyodo I. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2020 Nov;86(5):607-618. doi: 10.1007/s00280-020-04135-8. Epub 2020 Sep 23. Erratum In: Cancer Chemother Pharmacol. 2021 Apr;87(4):585-586.
Results Reference
derived

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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

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