drugset / Trial / NCT01548144

Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer

NCT01548144

Phase 1 Terminated 178 enrolled M.D. Anderson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed) or of the combination of 3 study drugs that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied. Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth and survival. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Pemetrexed is designed to block proteins that may cause tumors to grow. This is an investigational study. Crizotinib is FDA approved and commercially available for the treatment of locally advanced or metastatic non-small cell lung cancer. Pazopanib is FDA approved and commercially available for treatment of advanced renal cell carcinoma. Pemetrexed is FDA approved and commercially available for the treatment of non-small cell lung cancer. The combination of crizotinib with pazopanib, crizotinib with pemetrexed, pazopanib with pemetrexed, and giving all 3 drugs together to patients with advanced cancer is investigational. Up to 364 patients will take part in this study. All will be enrolled at MD Anderson.

Timeline

Start
2012-04
Primary completion
2021-08-26
Completion
2021-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Crizotinib Small molecule 250 mg Oral
Subject Pazopanib Small molecule 200 mg Oral
Subject Pemetrexed Small molecule 200 mg/m2 Intravenous
Subject Pemetrexed Small molecule 400 mg/m2 Intravenous