NCT01331941

A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function

An Open-label Pharmacokinetic Study of AMG 386 in Advanced Cancer Subjects With Normal and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Kidney Disease
• Renal Impairment

Interventions

Type	Name	Description
DRUG	AMG 386 + Paclitaxel	15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m\^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent.
DRUG	AMG 386	15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.

Timeline

• Start date: 2011-09-19
• Primary completion: 2013-02-26
• First posted: 2011-04-08
• Last updated: 2017-11-06

Locations

4 sites across 1 country: United States