Solid Tumor Clinical Trial
Official title:
Pharmacokinetics of Enzastaurin HCl in Native Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma
The purpose of this study is to assess the pharmacokinetics (PK) of enzastaurin and its
metabolites in native Chinese participants with advanced and/or metastatic solid tumors or
lymphoma. Information about any side effects that may occur will also be collected. Treatment
of disease is not the main purpose of the study.
This is a Phase 1 study of enzastaurin in native Chinese participants with advanced and/or
metastatic solid tumors or lymphoma. Participants will receive daily doses of enzastaurin for
14 days, stop dosing for 3 days during PK sampling, and resume dosing on Day 18. Participants
may be allowed to receive enzastaurin for approximately 2 to 4 weeks after day 18 to provide
an opportunity for a participant's oncologist to assess the potential benefit of the
participant continuing to receive enzastaurin in the safety extension phase. There is no
planned duration for the extension phase; participants are allowed to continue receiving
enzastaurin until disease progression or other reason for discontinuation as per the
investigator's assessment.
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