Status:
COMPLETED
A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma
Lead Sponsor:
Cytokinetics
Conditions:
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study was an early-phase trial arranged into two phases. The Phase I portion was a dose-escalation study designed to assess the safety, tolerability and to identify the maximum tolerated dose of ...
Eligibility Criteria
Inclusion
- Phase 1: Patients with evaluable or measurable (by MRI or CT) Hodgkin's Disease or Non-Hodgkin's Lymphoma. Phase 2: Patients with Measurable Non-Hodgkin's Lymphomas (Indolent or Aggressive) only. - Patients with Indolent NHL must be relapsed or refractory to at least one prior line of therapy (CHOP, CVP, chlorambucil or fludaribine). Prior treatment with Rituximab is required. - Patients with Aggressive NHL refractory to (or relapsed from) at least one CHOP-based therapy who have had prior treatment with Rituximab and who are not candidates for high-dose chemotherapy or autologous stem cell transplantation. - ECOG performance status 0-2 - Autologous stem cell transplant recipients are eligible if 100 days have elapsed since procedure.
Exclusion
- Phase 1: History of prior radioimmunotherapy (Bexxar, Zevalin); These patients ARE permitted in the Phase 2 trial. - Current active malignancy besides NHL, except excised non-melanoma skin cancer, in-situ cervical or bladder cancer or early stage prostate cancer. - Patients with leptomeningeal of CNS lymphoma - Known allergy to and/or receipt of treatments contraindicated by administration of G-CSF - Patients with active Hepatitis B or C, or patients with HIV infection. - Pregnant or breast-feeding females. - Previous treatment with a KSP inhibitor
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00343564
Start Date
April 1 2006
End Date
July 1 2010
Last Update
January 13 2020
Active Locations (8)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
2
Cornell University Medical Center
New York, New York, United States, 10021
3
Memorial Sloan-Kettering Caner Center
New York, New York, United States, 10021
4
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032