Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)
- Conditions
- Neoplasms, Breast
- Interventions
- Registration Number
- NCT00388076
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Pazopanib pazopanib and paclitaxel Part 1 paclitaxel pazopanib and paclitaxel Part 2 Pazopanib pazopanib, paclitaxel, and carboplatin Part 2 paclitaxel pazopanib, paclitaxel, and carboplatin Part 2 carboplatin pazopanib, paclitaxel, and carboplatin Part 3 Pazopanib pazopanib, paclitaxel, and lapatinib Part 3 Lapatinib pazopanib, paclitaxel, and lapatinib Part 3 paclitaxel pazopanib, paclitaxel, and lapatinib
- Primary Outcome Measures
Name Time Method Adverse Effects, Laboratory parameters before and after taking the study medications.
- Secondary Outcome Measures
Name Time Method Blood samples over a 24 hour period Tumors will be measured at routine intervals throughout (e.g. by CT scan).
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Nashville, Tennessee, United States