Spots Global Cancer Trial Database for A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)
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Trial Identification
Brief Title: A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)
Official Title: 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
Study ID: NCT00499239
Interventions
Study Description
Brief Summary: Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts. Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.
Detailed Description: 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 population. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF, San Francisco, California, United States
Northwestern University, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fakultni nemocnice Brno - Bohunice, Brno, , Czech Republic
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czech Republic
Fakultni nemocnice Olomouc, Olomouc, , Czech Republic
Fakultni nemocnice Kralovske Vinohrady, Praha, , Czech Republic
Vseobecna fakultni nemocnice, Praha, , Czech Republic
State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences, Kaluga Region, , Russian Federation
State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia, Moscow, , Russian Federation
State Institution Hematological Research Center under the Russian Academy of Medical Sciences, Moscow, , Russian Federation
Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin, Moscow, , Russian Federation
Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways", Moscow, , Russian Federation
State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital, Novosibirsk, , Russian Federation
Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care, St Petersburg, , Russian Federation
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, Institute of Hematology and Transplantology n.a. R.M. Gorbacheva, St. Petersburg, , Russian Federation
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, St. Petersburg, , Russian Federation
Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care, St. Petersburg, , Russian Federation
Contact Details
Name: Michael Hawkins, MD
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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