At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 79 enrolled
Drug / intervention
ART-123 (3-day ART) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ART-123 (3-day ART), ART-123 (1-day ART), and 1 other intervention for Postoperative Stage II/III Colon Cancer. Completed, enrolled 79 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Stage II/III Colon Cancer
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJul 2016
Primary CompletionFeb 2018
TodayJul 2026
First PostedJun 8, 2016
Enrollment StartJul 1, 2016
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.1 years ago
Interventions
ART-123 (3-day ART)drug
ART-123 380 U/kg infusion once daily on days 1-3 in each cycle
ART-123 (1-day ART)drug
ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle
Placebodrug
Placebo infusion once daily on days 1-3 in each cycle