Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies
Status:
Completed
Trial end date:
2018-12-18
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of
2 phases:
Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics
(Food Effect) with an Extension
This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with
hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that
have originated or metastasized to the liver for which no standard treatment exists or have
progressed or recurred following prior therapy. Subjects must not be eligible for therapy of
higher curative potential where an alternative treatment has been shown to prolong survival
in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate
in this study.