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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 94 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02665416
The ClinicalTrials.gov registry entry for NCT02665416 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT02665416 reports 0 study locations.
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.
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