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NCT02665416 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
NCT02665416: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02665416 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 94 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02665416, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
Study Summary
This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose.
Primary Outcome
From Day (D) 1 until D28 of Cycle (C)1 (cycle length=28 days)
Interventions
- DRUG Bevacizumab
- DRUG Selicrelumab
- DRUG Vanucizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2016-01-25 |
| Est. Completion | 2019-10-30 |
| Phase | Phase 1 |
What the finished NCT02665416 record still lists
NCT02665416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT02665416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02665416 about?
NCT02665416 is a clinical study titled "Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors". This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the max...
What is the current status of trial NCT02665416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2016-01-25. Estimated completion is 2019-10-30.
What interventions are being tested in trial NCT02665416?
The interventions under investigation include: Bevacizumab (DRUG), Selicrelumab (DRUG), Vanucizumab (DRUG).
Who is sponsoring clinical trial NCT02665416?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02665416's enrollment target sits among peer trials
94 615th of 2000 higher than 1,377 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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