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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Roman Pérez-Soler, M.D.
Montefiore Medical Center (NY - USA)
United States: Food and Drug Administration
|Montefiore Medical Center||Bronx, New York 10467-2490|