drugset / Trial / NCT00504790

Phase I Study to Assess the Safety, Pharmacokinetics, & Pharmacodynamics of GSK923295 in Subjects w/ Refractory Cancer

NCT00504790 ↗

Phase 1 Completed 39 enrolled GlaxoSmithKline
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase I, open-label, first time in human study of GSK923295, in adult subjects with cancers that do not respond to standard therapy. This study will be conducted in two stages; a dose-escalation stage (Stage 1) and an expansion cohort stage (Stage 2).

Timeline

Start
2007-06-25
Primary completion
2012-05-07
Completion
2012-05-08

Publications

  • Results Chung V, Fleming RA, Johnson BM, Gauvin J, Cyr TL, Lager JJ, Lu E, Alberti DB, Williams B, Weber BL, Synold T, Holen KD. A phase 1 and first time in human study of the centromere associated protein E (CENP-E) inhibitor GSK923295A in patients with advanced solid rumors. American Association of Clinical Research Annual Meeting 2008, Oral Presentation, Abstract LB 246
  • Results Fleming RA, Holen KD, Cyr TL, Johnson BM, Gauvin JL, Lager JJ, Williams B, Alberti DB, Weber BL, Grilley-Olson JE, Chung V. A phase I dose escalation and pharmacokinetic study of the novel mitotic checkpoint inhibitor GSK923295A in patients with solid tumors. (Poster). EORTC/NCI/AACR Molecular Targets and Cancer Therapeutics Meeting, Geneva, Switzerland, 2008
  • Results Holen KD, Heath E, Shelman WS, Kirby LC, Johnson BM, Botbyl JD, Grilley-Olson JE, Lampkin TA, Chung V. Phase I, first-in-human study of the centromere-associated protein e (CENP-E) inhibitor GSK923295 in patients with advanced solid tumors (Study CPE107602). American Society of Clinical Oncology 2010, Oral Presentation, Abstract 3012

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK-923295A Small molecule — Intravenous

Indications