NCT00698243

Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.

Detailed description

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.

Conditions

• Any Solid Tumor or Lymphoma

Interventions

Type	Name	Description
DRUG	OSI-027	Administered orally

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2008-06-17
• Last updated: 2013-04-15

Locations

3 sites across 3 countries: United States, Belgium, United Kingdom