NCT00800345

Phase I Trial of Oral Metronomic Topotecan and Oral Pazopanib to Treat Recurrent/Persistent Gynecologic Tumors

A Phase I Trial of Oral Metronomic Topotecan in Combination With Oral Pazopanib Utilizing a Daily Dosing Schedule to Treat Recurrent or Persistent Gynecologic Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Vector Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors.

Detailed description

This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors. The study will include a Screening Phase, a Treatment Phase and a Followup Phase. In the Screening Phase the subject's eligibility for study participation will be determined; this phase can last up to 28 days. The Treatment Phase will begin when the subject starts study treatment and will continue until the subject is removed from study treatment. The Follow-up Phase will last for 30 days after the subject ends study treatment. The study will be conducted at approximately 1 site. Treatment cycle length is 28 days. Radiologic imaging will be repeated after every 2 cycles of treatment.

Conditions

• Gynecologic Tumors

Interventions

Type	Name	Description
DRUG	Oral Topotecan	Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
DRUG	Pazopanib	Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth.

Timeline

• Start date: 2009-04-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2008-12-02
• Last updated: 2017-03-28
• Results posted: 2017-02-23

Locations

1 site across 1 country: United States