Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination
with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to
determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in
combination with gemcitabine, to characterize the safety profile and feasibility of this
combination in patients with selected advanced solid tumors, to characterize the
pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity
in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics
(PGx) in tumor samples of patients exposed, in order to assess potential markers of response
and/or resistance.