Metastatic Solid Tumor Clinical Trial
Official title:
A Phase I, Dosage-finding and Pharmacokinetic Study of Intravenous Topotecan and Oral Erlotinib in Adults With Refractory Solid Tumors
The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.
The primary objectives of this trial include:
- To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in
combination with oral erlotinib.
- To define the dosage-limiting toxicities (DLT) of this combination.
- To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and
without erlotinib
The secondary objectives include:
- To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination
- To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and
topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in
peripheral blood samples and correlate these results with topotecan pharmacokinetics
- To measure the frequency of UGT genotypes in peripheral blood samples
- To evaluate the objective response rate using the RECIST criteria.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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