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

Asahi Kasei Medical

Status and phase: Completed; Phase 2

Conditions: Postoperative Stage II/III Colon Cancer

Treatments: Drug: ART-123 (1-day ART); Drug: ART-123 (3-day ART); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02792842

ART-123-201

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 3 patient groups, including a placebo group

ART-123 (3-day ART)

Experimental group

Treatment:

Drug: ART-123 (3-day ART)

ART-123 (1-day ART)

Experimental group

Treatment:

Drug: ART-123 (1-day ART)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo