TRINOVA-2: A Trial in Ovarian Cancer of AMG 386 + PLD

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. TRINOVA-2.

• IRAS ID

  67980

• Eudract number

  2009-017946-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• 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 enrolled. Approximately 380 patients will be randomized (allocated into groups by chance) in a 1:1 ratio to one of the following treatment arms:?½ Arm A: PLD 50 mg/m2 IV every 4 weeks, and blinded AMG 386 15 mg/kg IV weekly ?½ Arm B: PLD 50 mg/m2 IV every 4 weeks, and blinded placebo IV weeklyPLD stands for pegylated liposomal doxorubicin (a type of chemotherapy). Patients will have a 1 in 2 (50%) chance of receiving the investigational product called AMG 386, but all patients will receive PLD. 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 PLD 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 PLD after 6 cycles at the decision of the investigator. Patients who stop PLD for reasons other than cancer worsening (as shown on scans), 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 (as shown on scans), withdrawal of consent, or death, may continue to receive PLD. Patients will be evaluated every 8 weeks ñ 1 week for the first 64 weeks, then every 16 weeks ñ 1 week for the next 32 weeks, and then every 24 weeks ñ 4 weeks thereafter to assess the status of their tumour(s) using scans.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/EM/0040

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion