Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT02776683. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02776683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 7, 2016
- Primary completion
- Oct 2, 2018
- Completion
- Oct 2, 2018
- Last update posted
- Nov 20, 2019
2016 – 2018
United States locations
- U.S. sites
- 25
- U.S. states
- 10
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic-Arizona | Phoenix | Arizona | 85054 | — |
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | — |
| The Oncology Institute of Hope and Innovation | Anaheim | California | 92801 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Ashland Bellefonte Cancer Center | Ashland | Kentucky | 41101 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Aultman Hospital | Canton | Ohio | 44710 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | — |
| Northwest Cancer Specialists PC | Portland | Oregon | 97225 | — |
| Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | 97477 | — |
| Texas Oncology, P.A. | Abilene | Texas | 79606 | — |
| Texas Oncology, PA, | Amarillo | Texas | 79106 | — |
| Texas Oncology, P.A. | Austin | Texas | 78705 | — |
| Texas Oncology, P.A. | Flower Mound | Texas | 75028 | — |
| Texas Oncology, P.A. | Garland | Texas | 75042-5788 | — |
| Oncology Consultants, P.A. | Houston | Texas | 77030 | — |
| Texas Oncology, P.A. | McAllen | Texas | 78503-1298 | — |
| Texas Oncology, PA | Mesquite | Texas | 75150 | — |
| Texas Oncology-San Antonio Northeast | San Antonio | Texas | 78217 | — |
| Texas Oncology San Antonio Medical Center | San Antonio | Texas | 78229 | — |
| Tyler Hematology-Oncology, PA | Tyler | Texas | 75701 | — |
| Texas Oncology, P.A. | Tyler | Texas | 75702 | — |
| Texas Oncology, P.A., Deke Slayton Cancer Center | Webster | Texas | 77598 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02776683, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2019 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02776683 live on ClinicalTrials.gov.