Anlotinib in Ovarian Cancer

• Research type

  Research Study

• Full title

  A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818, a Dual Receptor Tyrosine Kinase, Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects with Recurrent or Metastatic, Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma

• IRAS ID

  304025

• Contact name

  Susana Banerjee

• Contact email

  Susana.Banerjee@rmh.nhs.uk

• Sponsor organisation

  Advenchen Laboratories LLC

• Eudract number

  2021-003871-32

• Clinicaltrials.gov Identifier

  NCT02584478

• Clinicaltrials.gov Identifier

  Not applicable,

• Duration of Study in the UK

  1 years, 11 months, 27 days

• Research summary

  This study is a Phase III, multi-centre, randomized trial with active control designed to evaluate the efficacy and safety of AL3818 8 mg plus background treatment (Active Arm) vs background treatment alone (Control Arm), where three background treatments, weekly paclitaxel, pegylated liposomal doxorubicin (PLD), and topotecan are utilized. Oral AL3818 8 mg may be given concurrently with background treatment or alone if the background treatment must be discontinued due to its toxicity for up to 24 cycles of therapy, in subjects with recurrent or metastatic platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  21/NE/0188

• Date of REC Opinion

  3 Dec 2021

• REC opinion

  Further Information Favourable Opinion