NiCCC Trial (BIBF1120)

• Research type

  Research Study

• Full title

  A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium

• IRAS ID

  119188

• Contact name

  Rosalind Glasspool

• Contact email

  ros.glasspool@ggc.scot.nhs.uk

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• Eudract number

  2013-002109-73

• ISRCTN Number

  ISRCTN50772895

• Clinicaltrials.gov Identifier

  GN12ON259, Sponsor Reference

• Duration of Study in the UK

  5 years, 6 months, 1 days

• Research summary

  Clear Cell Carcinomas (CCC) account for approximately 3-5% of endometrial and ovarian carcinomas and the prognosis for women with recurrent CCC of the ovary or endometrium is poor. Patients are routinely treated with chemotherapy, however the benefit gained from chemotherapy is limited with response rates of less than 10% and comes at the expense of toxicity of chemotherapy.
  Anti-angiogenic therapy has shown considerable benefit in CCC of the kidney. Laboratory studies indicate that inhibition of angiogenesis could also be of benefit in CCC of the ovary. Nintedanib is a potent oral triple angio-kinase inhibitor. Studies show Nintedanib is generally well tolerated without serious toxicity. It has shown promising results with chemotherapy in epithelial ovarian cancers as a whole and as a single agent in renal CCC. There is therefore a good rationale for assessing the efficacy of Nintedanib as a single agent in CCC of the ovary and endometrium.
  The purpose of this study is to compare Nintedanib to standard chemotherapy in patients with recurrent CCC the ovary or endometrium. The primary objective is to compare progression free survival. The secondary objectives are to assess overall survival, overall response rate, disease control rate at 12 weeks, toxicity, quality of life, quality adjusted time without symptoms of disease or toxicity of treatment (Q-TWIST), and treatment received post progression.
  Patients will be randomised to receive either:
  Nintedanib 200mg, orally, twice daily, continuously until disease progression or intravenous chemotherapy for 6 cycles. The chemotherapy regime will be chosen by the Investigator prior to randomisation from the following:

  Ovarian Cancer Patients
  Paclitaxel (80mg/m2): Day 1, 8, 15 every 28 days
  Pegylated Liposomal Doxorubicin (40mg/m2) every 28 days
  Topotecan 4mg/m2 Day 1, 8, 15 every 28 days

  Endometrial Cancer Patients
  Carboplatin (AUC 5) and Paclitaxel (175mg/m2) every 21 days
  Doxorubicin 60mg/m2 every 21 days

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  13/ES/0123

• Date of REC Opinion

  5 Nov 2013

• REC opinion

  Further Information Favourable Opinion