At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 430 enrolled
Drug / intervention
Ramucirumab +1 moredrug
Likely dose
Ramucirumab 8 mg/kgfrom 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.
A Phase III Study of RAMucirumab in Combination With TAS102 vs. TAS102 Monotherapy in Chemotherapy Refractory Metastatic Colorectal Cancer Patients
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·interventional·Posted May 11, 2018·Updated Aug 9, 2024
In Brief
A Phase 3 clinical trial evaluating Ramucirumab and TAS 102 for Colorectal Cancer. Completed, enrolled 430 participants across 28 sites.
Detailed Summary
Interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb study in patients with advanced metastatic colorectal cancer. The scope of the trial is to evaluate overall survival of either regimen (TAS102 +/- Ramucirumab) and evaluate safety and tolerability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesGermany
CollaboratorsEli Lilly and Company, Trium Analysis Online GmbH
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartJan 2019
Primary CompletionJul 2024
TodayJul 2026
First PostedMay 11, 2018
Enrollment StartJan 24, 2019
Primary CompletionJul 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 8.1 years ago
Interventions
Ramucirumabdrug
8 mg/kg iv over 60 min on d1+15, q4w
TAS 102drug
35mg/m2 p.o. twice daily (BID) d1-5 and d8-12, q4w