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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytokinetics
ClinicalTrials.gov Identifier:
NCT00343564
First received: June 21, 2006
Last updated: August 8, 2016
Last verified: August 2016

June 21, 2006
August 8, 2016
April 2006
July 2010   (final data collection date for primary outcome measure)
Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
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).
  • Phase 1: Determination of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) first without and then with administration of prophylactic G-CSF.
  • Phase 2: Frequency of Disease Response according to IWRC Criteria (Cheson,1999)
Complete list of historical versions of study NCT00343564 on ClinicalTrials.gov Archive Site
Phase 1: Pharmacokinetics of SB-743921 Administered on a Days 1 and 15 of a 28 Day Cycle. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Phase 1: Pharmacokinetics of SB 743921 administered on a Day 1 and Day 15 in a 28 Day Cycle.
  • Phase 2: Overall survival, progression-free survival. Time to and duration of response in patients who respond (CR, CRu, PR) to treatment. Frequency of disease response by (18-FDG PET), effects of SB-743921 on biomarkers
Not Provided
Not Provided
 
A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • 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.
  • Drug: SB-743921
    Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.
  • Experimental: Phase 1 Dose Escalation
    Phase 1 dose escalation without and with GCSF support
    Intervention: Drug: SB-743921
  • Experimental: Phase 2 Fixed Dose
    Phase 2 fixed dose based on Phase I findings stratified by NHL type
    Intervention: Drug: SB-743921
O'Connor OA, Gerecitano J, Van Deventer H, Hainsworth J, Zullo KM, Saikali K, Seroogy J, Wolff A, Escandón R. The addition of granulocyte-colony stimulating factor shifts the dose limiting toxicity and markedly increases the maximum tolerated dose and activity of the kinesin spindle protein inhibitor SB-743921 in patients with relapsed or refractory lymphoma: results of an international, multicenter phase I/II study. Leuk Lymphoma. 2015;56(9):2585-91. doi: 10.3109/10428194.2015.1004167.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
July 2010
July 2010   (final data collection date for primary outcome measure)
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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation
 
NCT00343564
CY 2121
Not Provided
Not Provided
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Cytokinetics
Cytokinetics
Not Provided
Principal Investigator: Owen O'Connor, M.D./Ph.D. Columbia University
Cytokinetics
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP