At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 123 enrolled
Drug / intervention
BI 695502 +1 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.
A Single Arm, Open-label, Multicenter, Multinational, Safety and Efficacy Phase IIIb Trial of BI 695502 Plus mFOLFOX6 in Patients With Previously Untreated Metastatic Colorectal Cancer
In Brief
A Phase 3 clinical trial evaluating BI 695502 and Avastin for Colorectal Neoplasms. Completed, enrolled 123 participants across 46 sites in 4 countries.
Detailed Summary
The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response \[CR\] plus partial response \[PR\]), overall survival (OS), duration of response (DOR), time to progression (TTP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesJapan, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJun 2016
Primary CompletionOct 2018
TodayJul 2026
First PostedMay 18, 2016
Enrollment StartJun 8, 2016
Primary CompletionOct 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.1 years ago
Interventions
BI 695502drug
Avastindrug