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