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Trial record 3 of 5 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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02792842
Recruitment Status : Active, not recruiting
First Posted : June 8, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. NCI-CTCAE [ Time Frame: 24 weeks ]
  2. FACT-G: Functional Assessment of Cancer Therapy - General [ Time Frame: 24 weeks ]
  3. Discontinuation/ suspension/dose reduction of chemotherapeutic agents [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792842


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

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT02792842     History of Changes
Other Study ID Numbers: ART-123-201
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

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