A Study of MK-8109 (Vintafolide) Given Alone or With Chemotherapy in Participants With Advanced Cancers (MK-8109-001)
Status:
Terminated
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
This trial will be conducted in three parts. Part A is a dose escalation trial followed by a
dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. The
primary hypothesis of this trial is that administration of vintafolide in combination with
carboplatin and paclitaxel is safe and tolerable. Part B is a single dose, dose escalation,
pharmacokinetic (PK), and QTc interval trial. The primary objectives include determination of
the maximum single tolerated dose of vintafolide and to evaluate the effect of this single
maximum dose on the QTc interval. Part C is a weekly dose escalation trial of vintafolide
followed by a dose confirmation. The primary hypothesis of this part is that weekly
vintafolide has acceptable safety and tolerability in participants with advanced cancers.