Phase I Study of GX15-070 (NSC # 729280) and Bortezomib in Aggressive Relapsed/Recurrent Non-Hodgkin's Lymphoma
I. To establish the maximum tolerated dose of obatoclax mesylate when administered with
bortezomib in patients with aggressive relapsed or recurrent non-Hodgkin lymphoma.
II. To describe the toxicities of this regimen at each dose studied in these patients.
III. To characterize the pharmacokinetic behavior of this regimen in these patients.
IV. To obtain preliminary information regarding the effect of obatoclax mesylate on several
apoptotic regulatory pathways.
V. To document all clinical responses in these patients to this regimen.
OUTLINE: This is a multicenter study.
PHASE I: Patients receive obatoclax mesylate IV over 3 hours followed by bortezomib IV on
days 1, 8, 15, and 22.
Treatment repeats every 35 days in the absence of disease progression or unacceptable
toxicity. Pharmacokinetic evaluations of obatoclax mesylate are conducted in all patients
during the first course.
PHASE II: Patients receive obatoclax mesylate IV over 3 hours followed by bortezomib IV on
days 1, 8, 15, and 22 at the maximum tolerated dose determined in phase I.
Treatment repeats every 35 days for up to 1 year in the absence of disease progression or
unacceptable toxicity. After completion of study treatment, patients are followed for 26
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of obatoclax mesylate when administered with bortezomib
Defined as the highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. Graded according to the NCI CTCAE, Version 3.0.
City of Hope Medical Center
United States: Food and Drug Administration
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