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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 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 35 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01331941
The ClinicalTrials.gov registry entry for NCT01331941 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 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 AMG 386 is the first listed.
NCT01331941 reports 0 study locations.
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.
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