Trials / Completed
CompletedNCT02792842
Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Asahi Kasei Therapeutics Corporation · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ART-123 (3-day ART) | ART-123 380 U/kg infusion once daily on days 1-3 in each cycle |
| DRUG | 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 |
| DRUG | Placebo | Placebo infusion once daily on days 1-3 in each cycle |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2018-02-01
- Completion
- 2018-02-01
- First posted
- 2016-06-08
- Last updated
- 2024-04-04
- Results posted
- 2024-04-04
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02792842. Inclusion in this directory is not an endorsement.