Phase III trial of tesetaxel as second-line therapy in Gastric cancer

Trial Profile

Phase III trial of tesetaxel as second-line therapy in Gastric cancer

Planning
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2011

At a glance

  • Drugs Tesetaxel (Primary)
  • Indications Gastric cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Genta (CEASED)
  • Most Recent Events

    • 29 Jun 2011 A request for Special Protocol Assessment (SPA) will be submitted to the US FDA in Q3 of 2011, according to Genta media release.
    • 04 Jun 2011 Phase II results presented at ASCO suggest a starting dose of 27 mg/m2 with escalation to 35 mg/m2. The trial will proceed with a q3w schedule.
    • 16 Dec 2010 The trial could commence in 2011, pending completion of global regulatory review, according to a Genta media release.
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