NCT01407562

Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors

Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.

Detailed description

This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).

Conditions

• Unspecified Adult Solid Tumor - Protocol Specific
• Breast Cancer - Female

Interventions

Type	Name	Description
DRUG	Pazopanib	Starting dose is 400 given on Days 2-5, 9-12, and 16-26 of each 28 day cycle
DRUG	Paclitaxel	Starting dose is 60 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle
DRUG	Carboplatin	Starting dose of carboplatin that corresponds to an AUC of 2, IV on days 1, 8, and 15 of each 28 day cycle

Timeline

• Start date: 2010-09-17
• Primary completion: 2016-03-29
• Completion: 2016-03-29
• First posted: 2011-08-02
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States