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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: Completed Phase 1 study, sponsored by Amgen.

NCT00858377 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 95 participants
Start Date 2009-08-10
Est. Completion 2019-04-03
Phase Phase 1
Amgen

558 total trials

What the finished NCT00858377 record still lists

NCT00858377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).

The record links to 0 conditions, and to 2 interventions - of which Arm 1- Dose Escalation is the first listed.

NCT00858377 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00858377's enrollment target sits among peer trials

95 610th of 2000 higher than 1,386 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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Source: ClinicalTrials.gov NCT00858377, the US trial registry maintained by the National Library of Medicine. NCT00858377 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.