Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients
The goal of this clinical research study is to find the highest tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.
Pazopanib is designed to block different receptors in the cancer cells that ultimately are responsible for the growth of the tumor and its blood vessels.
Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also involved in cancer growth.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I Combination of Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients With Advanced Solid Tumors Refractory to Standard Therapy|
- Maximum Tolerated Dose (MTD) of Pazopanib and Everolimus [ Time Frame: 28 days ]MTD defined as highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) was less than 33%, with no more than 1 of 6 evaluable participants had a DLT using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Response.of Pazopanib and Everolimus [ Time Frame: 4 months ]Response evaluated using following criteria: Stable disease for more than or equal to 4 months.
- Response.of Pazopanib and Everolimus [ Time Frame: 4 months ]Response evaluated using following criteria: Decrease in measurable tumor (target lesions) by more than or equal to 20% by RECIST criteria.
- Response.of Pazopanib and Everolimus [ Time Frame: 4 months ]Response evaluated using following criteria: Decrease in tumor markers by more than or equal to 25% (for example, a >/= 25% decrease in PSA for patients with prostate cancer.
|Actual Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Pazopanib + Everolimus
Pazopanib 200 mg and Everolimus 5.0 mg oral dosing every other day (except for lead in 5 days of Cycle 1 where both drugs administered daily).
Starting Dose: 200 mg by mouth on Days 1 - 5 of Cycle 1 only. On Day 6 and every cycle-day with an even number, only pazopanib administered.
Other Name: GW786034Drug: Everolimus
Starting dose: 5.0 mg by mouth on Days 1 - 5 of Cycle 1. On Day 7 and every cycle-day with an odd number, only everolimus will be administered.
Dose Expansion Phase: Maximum tolerated dose (MTD) from lead in phase.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01430572
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David S Hong, MD||M.D. Anderson Cancer Center|