Multi-center, Open-label, Dose-escalating Phase I/II Trial of GS-9219 Administered Once Every Three Weeks Intravenously to Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma or Multiple Myeloma
The primary objective of this study is as follows:
To assess the safety, toxicity, and maximum tolerated dose (MTD) of GS 9219 administered via
IV administration once every three weeks (21 days) for six treatment cycles, i.e. for a
total of 18 weeks, in patients with relapsed or refractory Chronic Lymphocytic Leukemia
(CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM).
The secondary objectives of this study are as follows:
To determine the pharmacokinetic parameters of GS 9219 for this regimen and patient
To assess the antitumor activity of GS 9219 based on Response Rate and Duration of Response.
Progression-free Survival and Overall Survival will be assessed if applicable.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety- Toxicity will be graded according to the NCI CTCAE. The MTD will be the highest dose level immediately below the dose level where two or more of three to six patients experienced DLT.
Michael Hawkins, MD
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|UCSF||San Francisco, California 941430324|
|Northwestern University||Chicago, Illinois 60611|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Nevada Cancer Institute||Las Vegas, Nevada 89135|