CUDC-101 in patients with HER2-positive invasive breast cancer

• Research type

  Research Study

• Full title

  A Phase 1 open-label study to investigate the pharmacodynamics, metabolomics and pharmacokinetics of CUDC-101 in subjects with HER2 positive invasive breast cancer.

• IRAS ID

  111948

• Contact name

  Sarah Blagden

• Sponsor organisation

  Curis, Inc.

• Eudract number

  2012-003064-47

• ISRCTN Number

  n/a

• Research summary

  This is a Phase I, open-label study of the pharmacodynamic effects of CUDC-101 in subjects with HER2 positive or HER2/EGFR double positive invasive breast cancer. CUDC-101 is a new drug that simultaneously inhibits HER2 and EGFR proteins. Women with invasive Her2 positive breast cancer are eligible for this study. A total of 20 patients will be treated intravenously with CUDC-101 at a dose of 275 mg/m2, once daily for 5 consecutive days. 275 mg/m2 was the dose was found to be generally well tolerated in previous studies. The first 10 subjects will be enrolled into Cohort 1 and the following 10 subjects will be enrolled into cohort 2. All subjects will have tumour biopsies taken pre-treatment. Cohort 1 subjects will undergo a post-treatment biopsy on Day 5 (after the 5th infusion of CUDC-101) and cohort 2 subjects will have a post- treatment biopsy on day 1 (after their first infusion of CUDC-101). Subjects will be newly diagnosed with invasive HER2-positive breast cancer and amenable to a short (5 day) course of treatment with CUDC-101 study treatment administered during the time between their initial diagnosis of breast cancer and subsequent treatment (e.g. surgery or chemotherapy) without significantly delaying such treatment. The maximum duration of participation is approximately 26 days, including up to 14 days for screening, 5 days of study treatment (Monday to Friday) and 7 days safety follow up. Blood and urine samples will be taken for routine laboratory testing (Biochemistry and haematology) pharmacodynamics and pharmacokinetics. The study will be conducted at a single site, the Hammersmith Hospital, London, with patients being referred from Charing Cross Hospital. Both hospitals are part of Imperial College Healthcare NHS Trust. The study is expected to last approximately 13 months.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/1555

• Date of REC Opinion

  11 Dec 2012

• REC opinion

  Further Information Favourable Opinion