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A Phase I Study of GSK2141795 in Patients with Solid Tumors or Lymphomas
[Protocol 09-023]
- Full Title :
- A PHASE I, OPEN-LABEL, TWO-STAGE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF THE ORAL AKT INHIBITOR GSK2141795 IN SUBJECTS WITH SOLID TUMORS OR LYMPHOMAS
- Purpose :
The purpose of this study is to find the highest dose of an investigational drug called GSK2141795 that can be given safely in patients with advanced solid tumors and lymphomas that persist despite standard therapy or for which no standard therapy exists. Researchers will also analyze how GSK2141795 is taken up by the body and how it affects cancer cells.
GSK2141795 works by blocking a protein kinase called AKT, an enzyme which signals some cancer cells to grow and divide faster. AKT is also involved in insulin signaling, so high glucose levels may also occur when AKT is blocked.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of an advanced solid tumor or lymphoma that persists despite standard therapy or for which no standard therapy exists
- At least 4 weeks must have passed since completion of prior therapy and entry into the study, and patients must have recovered from any side effects.
- Patients with type 1 or 2 diabetes may not participate.
- 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 and to inquire about eligibility for this study, please contact Dr. Carol Aghajanian at 212-639-2252.
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