A Phase 1 Dose-escalation Study of Intermittent, Once Weekly, and Continuous Daily Oral OSI-027 Dosing in Patients With Advanced Solid Tumors or Lymphoma
The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2,
weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of
clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will
be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment
Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended
phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
21 days
Yes
Medical Monitor
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
OSI-027-101
NCT00698243
June 2008
February 2013
Name | Location |
---|---|
Karmanos Cancer Institute | Detroit, Michigan 48201 |