NCT00561795

Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors

A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women With Newly Diagnosed, Previously Untreated, Gynaecological Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.

Conditions

• Primary Peritoneal Carcinoma
• Tumor
• Epithelial Ovarian Cancer
• Uterine Disease
• Cervix Diseases
• Neoplasms, Ovarian
• Cancer

Interventions

Type	Name	Description
DRUG	pazopanib (GW786034)	800 mg orally once a day for 6 cycles
DRUG	carboplatin	IV over one hour every 3 weeks of 6 cycles
DRUG	paclitaxel	IV 175 mg/m\^2 given over 3 hours on day one of a 21 day cycle for six cycles

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-11-21
• Last updated: 2012-03-22
• Results posted: 2010-12-07

Locations

5 sites across 2 countries: France, Germany