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

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

1.1 Primary Objective(s)
1.1.1 Determine the safety and tolerability of pazopanib in combination with weekly paclitaxel and weekly carboplatin on Days 1, 8, and 15 every 28 days in patients with advanced solid tumors.
1.1.2 Determine the maximum tolerated dose (MTD) of pazopanib in combination with weekly paclitaxel and weekly carboplatin on Days 1, 8, and 15 every 28 days in patients with advanced solid tumors.
1.1.3 Determine the effect of pazopanib on the pharmacokinetics of paclitaxel and carboplatin.
1.2 Secondary Objective(s)
1.2.1 Assess the clinical activity of pazopanib in combination with paclitaxel and carboplatin administered weekly in patients with solid tumors and in a cohort of triple-negative breast cancer patients.
1.2.2 Evaluate the change in circulating tumor cells in peripheral blood serially in patients enrolled in the dose expansion.
1.2.3 Evaluate blood-based biomarkers, such as cytokines and angiogenic factors (CAF) as potential markers for biological activity, therapeutic sensitivity, or resistance, in patients enrolled in the dose expansion.

Protocol Number051101
Principal InvestigatorAntoinette Tan
PhasePhase I
ScopeLocal
Applicable Disease SitesBreast - Female
Any Site
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedGW786034 (PAZOPANIB)
CARBOPLATIN
PACLITAXEL
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.