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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

A

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

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

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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