NCT01600573

Pazopanib and Weekly Topotecan in Patients Recurrent Ovarian Cancer (TOPAZ)

A Phase I/II Study of Pazopanib and Weekly Topotecan in Patients With Platinum-resistant or Intermediate-sensitive Recurrent Ovarian Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: JSehouli · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial shall clarify the efficacy and safety of pazopanib in combination with weekly topotecan in patients with platinum-resistant or intermediate platinum-sensitive recurrent epithelial ovarian cancer, fallopian and peritoneal carcinoma

Detailed description

This study is a prospective single-arm, open-label, multicenter phase I/II trial. The phase I-trial is a dose-escalation trial to determine the maximum tolerated dose (MTD) of pazopanib in combination with weekly topotecan. The phase II-trial is a single arm open-label trial to further assess the safety and the efficacy of this combination of treatment.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	pazopanib in combination with weekly topotecan	* Topotecan as an IV infusion over 30 minutes on days 1, 8, and 15 of a 28 day cycle and * Pazopanib orally once daily continuous dosing in the following dose levels: Phase I Trial: Dose level -I: Topotecan weekly 3mg/m2, Pazopanib 400 mg Dose level I: Topotecan weekly 4mg/m2, Pazopanib 400 mg Dose level II: Topotecan weekly 4mg/m2, Pazopanib 600 mg Dose level III: Topotecan weekly 4mg/m2, Pazopanib 800 mg Phase II Trial: Phase II will either use the MTD as determined in Phase I or a lower dose if deemed necessary.

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2012-05-17
• Last updated: 2016-10-11

Locations

1 site across 1 country: Germany