TRINOVA-1

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

• IRAS ID

  100203

• Contact name

  Steve Chan

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2010-019821-32

• Clinicaltrials.gov Identifier

  NCT01204749

• Research summary

  This is a phase 3, global, multicentre study. Patients with epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer; which has returned (recurrent) and is partially sensitive or resistant to platinum-containing chemotherapy, will be able to take part. Approximately 900 patients will be recruited (allocated into groups by chance) in a 1:1 ratio to one of the following treatment arms:?½ Arm A: Paclitaxel 80 mg/m2 IV QW (3 weeks on/1 week off), and AMG 386 15 mg/kg IV weekly ?½ Arm B: Paclitaxel 80 mg/m2 IV QW (3 weeks on/1 week off), and placebo IV weekly Patients will have a 1 in 2 (50%) chance of receiving the investigational product called AMG 386, but all patients will receive Paclitaxel. The placebo is a dummy treatment containing no active ingredient. This study is double-blind which means neither the patient, investigator or sponsor will know which of the 2 treatment arms the patient is receiving. Patients will continue to receive Paclitaxel plus AMG 386 or placebo (depending on treatment arm) until their cancer worsens (as shown on scans), or for unacceptable side-effects, if they withdraw consent, or until they die. Patients may stop Paclitaxel if they have a complete response and the investigator feels that they will derive no additional benefit. Patients who stop Paclitaxel for reasons other than cancer worsening, withdrawal of consent, or death should continue to receive AMG 386 or placebo. Patients who stop AMG 386 or placebo for reasons other than cancer worsening, withdrawal of consent, or death, may continue to receive Paclitaxel. Patients will be evaluated every 8 weeks ñ 1 week for the first 2 years, then every 6 months ñ 1 month thereafter to assess the status of their tumour(s) using scans.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0344

• Date of REC Opinion

  30 Apr 2012

• REC opinion

  Further Information Favourable Opinion