A Phase I Study of BKM120 with Carboplatin and Paclitaxel in Patients with Advanced Solid Tumors

Protocol
10-192
Full Title
A Phase I Study of BKM120 + Carboplatin + Paclitaxel for Patients with Advanced Solid Tumors
Phase
I
Purpose

Carboplatin and paclitaxel are standard drugs used to treat many types of cancer. BKM120 is an investigational drug that blocks a molecule called PI3 kinase, which appears to function abnormally in many cancers.

The goal of this study is to establish the highest dose of BKM120 that can be given safely with paclitaxel and carboplatin in patients with advanced solid tumors. All patients will be treated with standard doses of carboplatin and paclitaxel. Patients will be enrolled to receive treatment with one of three possible doses of BKM120.

BKM120 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 a recurrent or metastatic advanced solid tumor for which no curative therapy exists.
  • Patients may have had up to two prior regimens of chemotherapy for recurrent or metastatic cancer.
  • At least 4 weeks must have passed since completion of prior chemotherapy and radiation therapy and entry into the study (2 weeks since any major surgery), and patients must have recovered from any side effects.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew G. Fury at 646-888-4233.

Locations