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

• 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 ]

• 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)

• 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 ]

• 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

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.

• 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: 1
  Phase 1 dose escalation without and with GCSF support
  Intervention: Drug: SB-743921
• Experimental: 2
  Phase 2 fixed dose based on Phase I findings stratified by NHL type
  Intervention: Drug: SB-743921

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