Conditions: Non-Hodgkin's Lymphoma Hodgkin's Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 68
Healthy volunteers: no

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:

Arms:
arm 1: Phase 1 dose escalation without and with GCSF support arm 2: Phase 2 fixed dose based on Phase I findings stratified by NHL type

Interventions: intervention 1: SB-743921 intervention 2: SB-743921
Intervention descriptions: intervention 1: 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. intervention 2: Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Protocol document: