A Study of SB-743921 in Non-Hodgkin's Lymphoma


Tracking Information

Start Date  ICMJEApril 2006
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 16, 2008)
  • Phase 1: Determination of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) first without and then with administration of prophylactic G-CSF. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Phase 2: Frequency of Disease Response according to IWRC Criteria (Cheson,1999) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: June 21, 2006)
  • 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)
Change HistoryComplete list of historical versions of study NCT00343564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 23, 2008)
  • 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 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 [ Time Frame: >=28 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: June 21, 2006)
  • 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

Descriptive Information

Brief Title  ICMJEA Study of SB-743921 in Non-Hodgkin's Lymphoma
Official Title  ICMJEA 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
Brief Summary

Cytokinetics' CY 2121 Study is an early-phase trial arranged into two phases. The objectives of the first phase of the study are to assess the safety, tolerability and to identify the maximum tolerated dose of the drug SB-743921 in patients with Hodgkin's Disease and Non-Hodgkin's Lymphomas. The second phase of the study is designed to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively.

Detailed Description 
Study PhasePhase I, Phase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
Intervention  ICMJE
  • 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.
Study Arms / Comparison Groups
  • 1: Experimental
    Phase 1 dose escalation without and with GCSF support
    Intervention: Drug: SB-743921
  • 2: Experimental
    Phase 2 fixed dose based on Phase I findings stratified by NHL type
    Intervention: Drug: SB-743921

Recruitment Information

Estimated Enrollment  ICMJE100
Completion Date 
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: John Lewandowski, BS(609) 799-7580 ext 398jlewandowski@theradex.com
Location Countries  ICMJEUnited States,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00343564
Responsible PartyAndrew Wolff, M.D., F.A.C.C., Chief Medical Officer, Cytokinetics, Inc.
Study ID Numbers  ICMJECY 2121
Study Sponsor  ICMJECytokinetics
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Owen O'Connor, M.D./Ph.D.Columbia University
Information Provided ByCytokinetics