NCT00889382

A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

A Phase 1/2 Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors.

Detailed description

The phase 1 dose escalation portion will establish the maximum tolerated dose (MTD) in patients with advanced solid tumors. Once the recommended phase 2 dose (RP2D) is established for both schedules, the phase 2 study will begin. Patients with relapsed/recurrent epithelial ovarian cancer will be randomized 1:1:1 to 3 treatment groups.

Conditions

• Ovarian Cancer
• Solid Tumors

Interventions

Type	Name	Description
DRUG	OSI-906	Administered orally
DRUG	Paclitaxel	Administered intravenously

Timeline

• Start date: 2009-08-05
• Primary completion: 2014-08-01
• Completion: 2014-08-25
• First posted: 2009-04-28
• Last updated: 2024-11-20

Locations

46 sites across 10 countries: United States, Australia, Canada, Czechia, Italy, Poland, Romania, Russia, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study