NCT00884845

Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors

Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors

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

Summary

Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.

Detailed description

Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, determine the preliminary pharmacokinetics (PK) of the combination, evaluate the preliminary PK/pharmacodynamic correlation, evaluate the preliminary antitumor activity, perform a preliminary pharmacogenomic (PGx) study to explore molecular predictors of response to ErbB receptor antagonists and PM02734 in patient with advanced malignant solid tumors.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	PM02734 and erlotinib	PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion
DRUG	Erlotinib	Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-04-21
• Last updated: 2014-03-26

Locations

3 sites across 2 countries: United States, Spain