AZD2014 and Palbociclib w/ Horm.Therapy in Pts with Adv. Breast Cancer

• Research type

  Research Study

• Full title

  A Phase I/II Multicenter Study of the Combination of AZD2014 and Palbociclib on a background of Hormonal Therapy in Patients with Locally Advanced/Metastatic Estrogen Receptor Positive Breast Cancer Comprising a Safety, Pharmacokinetic and Preliminary Efficacy Evaluation followed by a Randomized, Double-Blind, Placebo-controlled, Parallel Group Extension (PASTOR)

• IRAS ID

  190303

• Contact name

  William Anja

• Contact email

  anja.williams@hcahealthcare.co.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2015-003320-30

• Duration of Study in the UK

  0 years, 10 months, 16 days

• Research summary

  This is a Phase I/II, international, multicentre study of the combination of AZD2014 and palbociclib on a background of 500 mg fulvestrant (referred to as the triplet) in
  postmenopausal women with locally advanced/metastatic estrogen receptor positive (ER+ve) breast cancer. It is anticipated that up to approximately 260 evaluable patients will be enrolled in total across the entire Phase I/II study.

  The study consists of three parts and patients will be enrolled into each part. Part A is a Phase I triplet dose finding phase in 3-6 patients per cohort and up to approximately 30 patients to determine the maximum tolerated dose (MTD). Part B is a Phase I single arm dose expansion. Part B consists of 3 phases. Part B1 is a single arm expansion in 9-15 patients evaluable for response to give a total of 15 patients evaluable for response at the dose under investigation. Part B2 is a single arm additional expansion(s) of Part B1 in up to 25 additional patients evaluable for response to give a total of 40 patients evaluable for response at the dose under investigation. Part B3 is a single arm drug-drug interaction (DDI) investigation in additional cohort(s) of approximately 9 patients. Part C is a Phase II, randomized, double-blind, group extension part in 180 patients (90 patients per each arm) comparing the triplet (AZD2014, palbociclib and fulvestrant) with doublet (palbociclib and fulvestrant). Patients will be assessed by the length of time during and after the treatment that the patient lives with the disease but it does not get worse. Measuring the progression-free survival is one way to see how well a new treatment works.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  15/LO/1818

• Date of REC Opinion

  5 Jan 2016

• REC opinion

  Further Information Favourable Opinion