NCT00343564

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin's Lymphoma
• Hodgkin's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2006-06-23
• Last updated: 2020-01-13
• Results posted: 2016-10-04

Locations

8 sites across 2 countries: United States, Russia