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

Postoperative Stage II/III Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792842
• Other study ID #: ART-123-201
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2024
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Postoperative Stage II/III Colon Cancer

Intervention

Drug:
• ART-123 (3-day ART)
ART-123 380 U/kg infusion once daily on days 1-3 in each cycle
• 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
• Placebo
Placebo infusion once daily on days 1-3 in each cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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.
Primary	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)