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

NCT02792842 | Completed Phase 2 Results

• 1 other identifier: ART-123-201
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Stage II/III Colon Cancer

Outcome Measures

Primary Outcomes (3)

• The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment

  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

  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)

  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）

Study Arms (3)

ART-123 (3-day ART)

EXPERIMENTAL

Drug: ART-123 (3-day ART)

ART-123 (1-day ART)

EXPERIMENTAL

Drug: ART-123 (1-day ART)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ART-123 (3-day ART) DRUG

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

ART-123 (3-day ART)

ART-123 (1-day ART) DRUG

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

ART-123 (1-day ART)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asahi Kasei Pharma Corporation: lead

Study Sites (2)

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Nerima City, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 32965539 DERIVED

MeSH Terms

Interventions

ART123

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Asahi Kasei Pharma Corporation

ct-info@om.asahi-kasei.co.jp

+81-3-6699-3600

Study Officials

• Asahi Kasei Pharma Corporation

  Asahi Kasei Pharma Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2016
• First Posted: June 8, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-03

Locations

JP (2)