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NCT02776683 · ClinicalTrials.gov registry record · Phase 3
Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
NCT02776683: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02776683 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 123 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02776683, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
Study 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).
Primary Outcome
The primary safety endpoint of the trial was patients with any of the following selected adverse events (AEs): * Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions), * Thromboembolic events (arterial or venous), * Gastrointestinal perforations, * Hypertension, * Proteinuria, * Pulmonary hemorrhage * All hemorrhages (including pulmonary hemorrhages) * Wound-healing complications/abscess/fistulas * Posterior reversible encephalopathy syndrome * Ovarian failure. All AEs w
Interventions
- DRUG Avastin
- DRUG BI 695502
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2016-06-08 |
| Est. Completion | 2018-10-03 |
| Phase | Phase 3 |
What the finished NCT02776683 record still lists
NCT02776683 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Avastin is the first listed.
NCT02776683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02776683 about?
NCT02776683 is a clinical study titled "Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer". 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 ...
What is the current status of trial NCT02776683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2016-06-08. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT02776683?
The interventions under investigation include: Avastin (DRUG), BI 695502 (DRUG).
Who is sponsoring clinical trial NCT02776683?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02776683's enrollment target sits among peer trials
123 1615th of 2000 higher than 384 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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