A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343564
Recruitment Status : Completed
First Posted : June 23, 2006
Results First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):

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 SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase II was intended to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the study was not initiated.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Hodgkin's Disease Drug: SB-743921 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Study to Determine the Safety, Pharmacokinetics and Potential Efficacy of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Dosing Schedule in Patients With Non-Hodgkin Lymphoma and Hodgkin Lymphoma
Study Start Date : April 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Phase 1 Dose Escalation
Phase 1 dose escalation without and with GCSF support
Drug: SB-743921
Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops.

Experimental: Phase 2 Fixed Dose
Phase 2 fixed dose based on Phase I findings stratified by NHL type
Drug: SB-743921
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Primary Outcome Measures :
  1. Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. [ Time Frame: 28 days ]
    Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).

Secondary Outcome Measures :
  1. Phase 1: Pharmacokinetics of SB-743921 Administered on a Days 1 and 15 of a 28 Day Cycle. [ Time Frame: 28 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: 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 Criteria: 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343564

United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Cornell University Medical Center
New York, New York, United States, 10021
Memorial Sloan-Kettering Caner Center
New York, New York, United States, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Sarah Cannon Cancer Research Institute
Nashville, Tennessee, United States, 37203
Russian Federation
Russian Medical Academy of Postgraduate Education
Moscow, Russian Federation, 115478
St. Petersburg State PAVLOV Medical University
Saint Petersburg, Russian Federation, 197002
Sponsors and Collaborators
Principal Investigator: Owen O'Connor, M.D./Ph.D. Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cytokinetics Identifier: NCT00343564     History of Changes
Other Study ID Numbers: CY 2121
First Posted: June 23, 2006    Key Record Dates
Results First Posted: October 4, 2016
Last Update Posted: October 4, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases