NCT01245543

Safety Study for Intravenous (IV) AC480 (AC480IV) to Treat Advanced Solid Tumors

Open-label, Phase 1 Trial to Evaluate the Safety and Pharmacokinetic Parameters of a 2-day Pulse of Intravenous (IV) AC480 (AC480IV) Administered as Monotherapy and in Combination With Docetaxel in Patients With Advanced Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AC480IV will be administered as a monotherapy and then in combination with docetaxel in patients with locally advanced or metastatic solid tumors for whom there are no standard or curative therapies available. It is designed to evaluate the safety and pharmacokinetic parameters of AC480IV as monotherapy and also in combination with docetaxel under the conditions of the study.

Detailed description

A Phase I study to determine safety and tolerability of AC480IV with and without Docetaxel in subjects with solid tumors.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	AC480IV	AC480IV will be administered as an infusion using a dose escalation design.
DRUG	Docetaxel	Docetaxel will be administered intravenously, initially as monotherapy and subsequently in combination with docetaxel immediately following AC480IV administration.

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2010-11-22
• Last updated: 2015-11-02

Locations

2 sites across 1 country: United States