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NCT00858377 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT00858377 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 95 participants.
The verdict
NCT00858377, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 42 subjects in three taxane-resistant tumor types. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study
Interventions
- DRUG Arm 1- Dose Escalation
- DRUG Arm 1- Dose Expansion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2009-08-10 |
| Est. Completion | 2019-04-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00858377
The ClinicalTrials.gov registry entry for NCT00858377 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Arm 1- Dose Escalation is the first listed.
NCT00858377 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00858377 about?
NCT00858377 is a clinical study titled "A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors". This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50 subjects may be enrolled in dose esca...
What is the current status of trial NCT00858377?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2009-08-10. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT00858377?
The interventions under investigation include: Arm 1- Dose Escalation (DRUG), Arm 1- Dose Expansion (DRUG).
Who is sponsoring clinical trial NCT00858377?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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