SAPPHIRE

• Research type

  Research Study

• Full title

  Efficacy and Safety of AP 12009 in Adult Patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) as Compared to Standard Treatment with Temozolomide or BCNU: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.

• Sponsor organisation

  Antisense Pharma GmbH

• Eudract number

  2007-005802-38

• ISRCTN Number

  ISRCTN

• Clinicaltrials.gov Identifier

  NCT

• Research summary

  This is a multi-national, multi-center study in adult patients who have brain tumours and whose disease is recurrent or unmanageable. In this study, the investigational drug, AP 12009, will be compared with standard chemotherapy treatments and suitable patients will be randomised (chosen by chance) to receive either AP 12009 treatment or standard treatment (Temozolomide [TMZ] or BCNU). AP 12009 will be applied intratumorally, while TMZ (Temozolomide) or BCNU will be administered according to established standard treatment regimes. The study will consist of a Screening period (max of 21 days), a Treatment period, a Post-Treatment Follow-up and a Post-Study Follow-up. The study treatments will be administered until the following occur:AP 12009 group: Until the disease gets worse or unacceptable toxicity occurs, or for a maximum of 11 treatment cycles TMZ group: Until the disease gets worse or unacceptable toxicity occurs, or for a maximum of 26 treatment cyclesBCNU group: Until the disease gets worse or unacceptable toxicity occurs, or for a maximum of 8 treatment cyclesTreatment cycles are defined as follows:AP 12009: Treatment cycle: 14 days (7 days on treatment and 7 days off treatment)TMZ: Treatment cycle: 28 days (drug application at Day 1 to 5, 23 days off treatment)BCNU: Treatment cycle: 42 days (drug application at Day 1, 41 days off treatment)After participation in the trial, patients are open to obtain any available treatment including current standard therapy as deemed appropriate by the treating physician.Throughout the study patients will undergo the following procedures: vital signs recorded, physical and neurological examinations, height and weight recorded, brain MRI scans, 12-lead ECGs, serum pregnancy tests (if applicable), x-rays, blood and urine samples taken for laboratory safety tests and pulmonary function test. Quality of Life questionnaires will also be completed throughout the study.

• REC name

  London - Central Research Ethics Committee

• REC reference

  09/H0718/13

• Date of REC Opinion

  10 Jun 2009

• REC opinion

  Further Information Favourable Opinion