NCT00404521

A Phase I Study of PM02734 in Subjects With Advanced Malignant Solid Tumors

A Phase I Single-institution, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM02734 Administered Every 3 Weeks, Intravenously, Over 30 Minutes, to Subjects With Advanced Malignant Solid Tumors.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: PharmaMar · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors.

Detailed description

Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors. Secondary objectives are to determine preliminary Pharmacokinetics of PM02734, to explore the relationships between pharmacokinetics and pharmacodynamics. To evaluate the preliminary pharmacokinetics/pharmacodynamics correlation and to evaluate the preliminary antitumor activity of PM02734. The trial will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	PM02734	Administered every 3 weeks, intravenously, over 30 minutes

Timeline

• Start date: 2005-08-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2006-11-28
• Last updated: 2014-03-26

Locations

1 site across 1 country: United States