NCT01238770

Phase I/II Study of Pazopanib and Cyclophosphamide in Patients With Platinum-resistant Recurrent Ovarian Cancer

A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Priv.-Doz. Dr. med. Joachim Rom · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer.

Detailed description

This study is a prospective open-label, non-randomized multicenter phase I/II trial in order to determine overall response rate of patients with platinum-resistant or refractory recurrent, pretreated epithelial ovarian cancer. In order to assure adequate toxicity assessment, a phase-I-trial is proponed. Phase II will be performed with MTD.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Pazopanib	Phase I Cyclophosphamid Pazopanib Dose level I 50 mg/day 400 mg/day Dose level II 50 mg/day 600 mg/day Dose level III 50 mg/day 800 mg/day Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally Phase II: Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally The dose for the phase II part of the trial will be based on the MTD of phase I.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-10-01
• Completion: 2015-10-01
• First posted: 2010-11-11
• Last updated: 2016-02-10

Locations

5 sites across 1 country: Germany