Trial record 3 of 6 for:    ART-123

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Asahi Kasei Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT02792842
First received: May 28, 2016
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Postoperative Stage II/III Colon Cancer
Drug: ART-123 (High Frequency)
Drug: ART-123 (Low Frequency)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Pharma Corporation:

Primary Outcome Measures:
  • NCI-CTCAE [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FACT-G: Functional Assessment of Cancer Therapy - General [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Discontinuation/ suspension/dose reduction of chemotherapeutic agents [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ART-123 (High Frequency) Drug: ART-123 (High Frequency)
intravenous drip infusion
Experimental: ART-123 (Low Frequency) Drug: ART-123 (Low Frequency)
intravenous drip infusion
Placebo Comparator: Placebo Drug: Placebo
intravenous drip infusion

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02792842

Contacts
Contact: Asahi Kasei Pharma Corporation ct-info@om.asahi-kasei.co.jp

Locations
Japan
Recruiting
Kobe, Hyogo, Japan
Recruiting
Nerima, Tokyo, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
Investigators
Study Chair: Asahi Kasei Pharma Corporation Asahi Kasei Pharma Corporation
  More Information

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT02792842     History of Changes
Other Study ID Numbers: ART-123-201 
Study First Received: May 28, 2016
Last Updated: July 12, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 28, 2016