NCT00388076

Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)

A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of Pazopanib in Combination With Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28-Day Cycle, Paclitaxel and Carboplatin on an Every 21 Days Schedule and Lapatinib and Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28- Day Cycle

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib (patients separated in each part). Toxicity monitoring will enable us to find the largest dose of pazopanib daily that can be safely given in combination with the chemotherapy agents TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest when these agents are given together and whether the combination of pazopanib with chemotherapy, helps to treat different types of cancer. Another objective is to find out how much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the agents are given. Collecting the blood samples requires that the patients remain in the vicinity of the clinic overnight on 2 occasions.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	Pazopanib	pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3
DRUG	Lapatinib	Lapatinib in combination with pazopanib and paclitaxel in Part 3
DRUG	paclitaxel	in combination with pazopanib
DRUG	carboplatin	in combination with pazopanib

Timeline

• Start date: 2006-04-28
• Primary completion: 2009-07-21
• Completion: 2009-07-21
• First posted: 2006-10-13
• Last updated: 2017-11-17

Locations

3 sites across 1 country: United States