A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma
- Registration Number
- NCT00343564
- Lead Sponsor
- Cytokinetics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 2 Fixed Dose SB-743921 Phase 2 fixed dose based on Phase I findings stratified by NHL type Phase 1 Dose Escalation SB-743921 Phase 1 dose escalation without and with GCSF support
- Primary Outcome Measures
Name Time Method Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. 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
Name Time Method Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Trial Locations
- Locations (8)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Memorial Sloan-Kettering Caner Center
🇺🇸New York, New York, United States
Cornell University Medical Center
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Russian Medical Academy of Postgraduate Education
🇷🇺Moscow, Russian Federation
St. Petersburg State PAVLOV Medical University
🇷🇺Saint Petersburg, Russian Federation
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Sarah Cannon Cancer Research Institute
🇺🇸Nashville, Tennessee, United States