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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion
Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets
Montefiore Medical Center
New York, New York, United States
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Intituto Universitario Dexeus
Barcelona, Barcelona, Spain
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
Time frame: 2 years
To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.
Time frame: 2 years
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