INCB 24360-210

• Research type

  Research Study

• Full title

  A RANDOMIZED, OPEN-LABEL, PHASE 2 STUDY OF THE IDO INHIBITOR INCB024360 (I) VERSUS TAMOXIFEN (C) FOR SUBJECTS WITH BIOCHEMICAL-RECURRENT-ONLY EPITHELIAL OVARIAN CANCER, PRIMARY PERITONEAL CARCINOMA, OR FALLOPIAN TUBE CANCER (P) FOLLOWING COMPLETE REMISSION WITH FIRST-LINE CHEMOTHERAPY

• IRAS ID

  108515

• Contact name

  Rebecca Kristeleit

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2012-001472-10

• ISRCTN Number

  not issued

• Research summary

  This is an open label study to evaluate, the efficacy, safety and tolerability of the investigational product in women with an elevated cancer antigen (CA-125) after a complete remission with first line chemotherapy of one of the following ovarian cancers: epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer. The product is compared to tamoxifen and consists of tablets that need to be administered in the morning and evening. On average patients are expected to receive treatment for 6 to 8 months and study visits will be conducted every 4 weeks (1 cycle of 28 days). In addition to the safety, tolerability and overall tumor response, the study will examine the level of investigational product in tumor samples and peripheral blood cells and assess the impact of treatment on plasma markers of inflammation.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/0984

• Date of REC Opinion

  16 Oct 2012

• REC opinion

  Further Information Favourable Opinion