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NCT01331941 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01331941: Completed Phase 1 study, sponsored by Amgen.
NCT01331941 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331941, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of renal dysfunction) will receive weekly doses of AMG 386 intravenously. The primary objective is to evaluate the pharmacokinetics (PK) of single agent AMG 386 in subjects with various degrees of renal function. Once the AMG 386 PK characterization is complete in the first 5 weeks of the study, all subjects will be allowed to continue to receive AMG 386 weekly only or subjects in group 1, 2 or 3 can opt to receive AMG 386 weekly in combination with paclitaxel until disease progression, unacceptable toxicity or withdrawal of consent.
Interventions
- DRUG AMG 386
- DRUG AMG 386 + Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2011-09-19 |
| Phase | Phase 1 |
What the finished NCT01331941 record still lists
NCT01331941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which AMG 386 is the first listed.
NCT01331941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331941 about?
NCT01331941 is a clinical study titled "A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function". This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of renal dysfunction) will receive weekly doses of AMG 386 intravenously. The primary objective is to evaluate the pharma...
What is the current status of trial NCT01331941?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2011-09-19.
What interventions are being tested in trial NCT01331941?
The interventions under investigation include: AMG 386 (DRUG), AMG 386 + Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01331941?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01331941's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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