Ridaforolimus Combination vs Monotherapy in Breast Cancer (MK8669-041)

• Research type

  Research Study

• Full title

  A Two-Part, Adaptive, Randomised Trial of Ridaforolimus in Combination with Dalotuzumab Compared to Exemestane or Compared to Ridaforolimus or Dalotuzumab Monotherapy in Oestrogen Receptor Positive Breast Cancer Patients

• IRAS ID

  56627

• Contact name

  Robert Charles Swanton

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2010-019867-13

• ISRCTN Number

  N/A

• Research summary

  This is a two-part, randomised, open-label, multi-centre, Phase 2 study of the combination of two experimental drugs known as ridaforolimus (MK8669) and dalotuzumab (MK0646) in post-menopausal women with advanced oestrogen receptor positive (ER) breast cancer. Ridaforolimus and dalotuzumab are being developed for the treatment of cancer. An earlier (phase 1) study of ridaforolimus and dalotuzumab in combination in patients with advanced solid tumours has shown clinical evidence of anti-tumour activity, including evidence in patients with advanced ER breast cancer. This study will look at the ridaforolimus and dalotuzumab combination specifically in advanced ER breast cancer patients. The study will be conducted in two parts. The purpose of the first part is to see how safe and well tolerated ridaforolimus and dalotuzumab are when given together in patients with breast cancer. The first part of the study will also look at whether the combination of ridaforolimus and dalotuzumab is more effective in breast cancer patients than a licensed breast cancer drug known as exemestane. The second part of the study will look to see if the combination of ridaforolimus and dalotuzumab is more effective than ridaforolimus by itself or dalotuzumab by itself in patients with breast cancer. Patients will be allowed to remain on study therapy for as long as they are deriving benefit. The study is being funded by the pharmaceutical company who is developing ridaforolimus and dalotuzumab. World-wide up to 380 patients will be recruited into this study. It is anticipated that two UK sites will participate in the study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/64

• Date of REC Opinion

  25 Nov 2010

• REC opinion

  Further Information Favourable Opinion