ONCX-NAV-G301 - REVELARE

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Open-Label, Randomized Study of Navicixizumab Plus Paclitaxel and Navicixizumab Monotherapy in Comparison to Paclitaxel Monotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

• IRAS ID

  300829

• Contact name

  Rebecca Kristeleit

• Contact email

  Rebecca.Kristeleit@gstt.nhs.uk

• Sponsor organisation

  OncXerna Therapeutics, Inc.

• Eudract number

  2021-001933-38

• Clinicaltrials.gov Identifier

  NCT05043402

• Duration of Study in the UK

  2 years, 7 months, 31 days

• Research summary

  The purpose of this research study is to determine the effectiveness of navicixizumab, the study medication, in treating epithelial ovarian, primary peritoneal or fallopian tube cancer when given alone and in combination with chemotherapy, paclitaxel.

  Navicixizumab may work by blocking the growth of cancer cells, and it may also prevent the growth of new blood vessels that tumours need to grow and spread.
  Paclitaxel is a commercially available chemotherapy treatment that is a commonly used in the treatment of ovarian cancer. Paclitaxel works by interfering with the growth of cancer cells and slows their growth and spread in the body.

  If a potential participant qualifies to enrol in the study based on the screening procedures, they will be assigned to receive one of the following treatments:
  • navicixizumab in combination with paclitaxel
  • paclitaxel given alone
  • navicixizumab given alone

  During the study participants will have tests and procedures that are part of their normal cancer care; these may be done more often because of study participation. They will also have some tests and procedures that are being performed as part of the study for research purposes (such as a biopsy of their tumour) or safety reasons. During the treatment phase of the study, participants will receive study medication. The study medication will be given in cycles that are 28 days long.

  Participants will take part in the study as long as they are doing well and their cancer has not gotten any worse.
  
  There is no guarantee that participants will directly benefit from taking part in this study.

  Approximately 400 participants in approximately 115 study sites across the world will be enrolled.

  The study is being sponsored by OncXerna Therapeutics, Inc., a US pharmaceutical company.

• REC name

  London - Central Research Ethics Committee

• REC reference

  21/LO/0871

• Date of REC Opinion

  18 Jan 2022

• REC opinion

  Further Information Favourable Opinion