A Phase II Study of BKM120 in Metastatic Transitional Cell Carcinoma of the Urothelium

Protocol
11-060
Full Title
Phase II Study of Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium
Phase
II
Purpose

The PI3 kinase (PI3K) pathway is a molecular signaling pathway that is activated in some cancers and promotes cancer growth. BKM120 is an investigational drug designed to kill cancer cells by inhibiting the PI3K pathway.

In this study, researchers are evaluating the safety and effectiveness of BMK120 in patients with metastatic transitional cell cancer of the urothelium (bladder, ureters, urethra, or renal pelvis) that has returned or continued to grow despite prior treatment. BMK120 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic transitional cell cancer of the urothelium (bladder, ureters, urethra, or renal pelvis) that has returned or continued to grow despite prior treatment.
  • Patients must have had treatment with at least one but no more than four anticancer drugs, including one of the following: cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine.
  • At least 4 weeks must have passed since completion of prior therapies (6 weeks since antibody therapy and 2 weeks since major surgery) before a patient enters the study.
  • Patients must be at least age 18.

For more information about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-422-4333.

Disease(s)
Bladder Cancer
Locations
Related Diseases