CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
SB-743921 +1 moredrug
Likely dose
SB-743921 2 mg/m2 (Phase 1 starting dose, escalating by 1 mg/m2); Phase 2 dose to be determinedAI-extracted
Key inclusion· 6
  • ✓Phase 2: Measurable Non-Hodgkin's Lymphomas (Indolent or Aggressive)
  • ✓Phase 2 Indolent NHL: Relapsed or refractory to at least one prior line of therapy (CHOP, CVP, chlorambucil or fludaribine) with prior treatment with Rituximab required
  • ✓Phase 2 Aggressive NHL: Refractory to or relapsed from at least one CHOP-based therapy with prior Rituximab treatment and not candidates for high-dose chemotherapy or autologous stem cell transplantation
  • ✓Phase 1: Evaluable or measurable Hodgkin's Disease or Non-Hodgkin's Lymphoma
Key exclusion· 6
  • ✕Phase 1: Prior radioimmunotherapy (Bexxar, Zevalin)
  • ✕Current active malignancy besides NHL/Hodgkin, except excised non-melanoma skin cancer, in-situ cervical or bladder cancer, or early stage prostate cancer
  • ✕Leptomeningeal or CNS lymphoma
  • ✕Active Hepatitis B or C or HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00343564
NCT00343564Phase 2Completed
CompareCT.gov

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

Cytokinetics·interventional·Posted Jun 23, 2006·Updated Jan 13, 2020

In Brief

A Phase 2 clinical trial evaluating SB-743921 for Non-Hodgkin's Lymphoma and Hodgkin's Disease. Completed, enrolled 68 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Hodgkin's Disease
CountriesRussia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 23, 2006
Enrollment StartApr 1, 2006
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.0 years ago

Interventions

SB-743921drug

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.

SB-743921drug

Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.