A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)

Stopped early · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00499239

Run by

Gilead Sciences

People needed

32

Starts

2007-07-01

Expected to finish

2010-10-01

Last updated by the study team

2014-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed or refractory CLL, NHL or MM
• ECOG Performance Status of 0, 1, or 2
• Adequate organ function (protocol defined)
• ECG without evidence of clinically significant ventricular arrhythmias

You may not qualify if…

• AIDS-related lymphoma
• Subjects with NHL who present exclusively with non-measurable lesions
• Subjects with MM who have non-secretory and/or non-measurable disease
• Recent anticancer therapy (chemotherapy, radiotherapy, and/or biotherapy)within four weeks prior to starting treatment
• Evidence of pulmonary fibrosis
• Other concurrent malignancy
• Uncontrolled concurrent illness
• Receiving chronic, systemically administered steroids
• Known hypersensitivity to nucleoside analogues

Where it is running

• 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, Czechia
• Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
• Fakultni nemocnice Olomouc — Olomouc, Czechia
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
• Vseobecna fakultni nemocnice — Prague, Czechia
• State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences — Kaluga Region, Russia
• State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia — Moscow, Russia
• State Institution Hematological Research Center under the Russian Academy of Medical Sciences — Moscow, Russia
• Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin — Moscow, Russia
• Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways" — Moscow, Russia
• State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital — Novosibirsk, Russia
• Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care — Saint Petersburg, Russia
• 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 — Saint Petersburg, Russia
• State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development — Saint Petersburg, Russia
• Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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