POSEIDON
Research type
Research Study
Full title
Phase I/prospective randomised phase II trial Of the Safety and Efficacy of tamoxifen in combination with the Isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alONe in hormone receptor positive, HER2 negative, metastatic breast cancer patients with prior exposure to endocrine treatment
IRAS ID
139349
Contact name
Richard Baird
Contact email
Sponsor organisation
The Netherlands Cancer Institute
Eudract number
2013-003947-51
Duration of Study in the UK
5 years, 4 months, 27 days
Research summary
GDC-0032 inhibits a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. Laboratory experiments have shown that GDC-0032 prevent or slow down the growth of many different types of human cancer cells.
The purpose of this study is to test the safety and efficacy of the GDC-0032 in combination with tamoxifen. The goal is also to determine a safe and tolerated GDC-0032 in combination with a fixed tamoxifen dose, how often it should be taken, how well patients with cancer can tolerate this combination. The drug will be mainly tested in patients with an advanced stage of breast cancer classified as hormone positive and HER2 negative.
There are two parts in this trial:
- A part 1: phase I where a small group of patients will received escalading dose of GDC-0032 in order to define the best dose to prescribe in the Part 2 of the trial.
- A part 2: a standard prospective, randomised controlled phase II clinical trial, comparing a standard arm (tamoxifen) to an experimental arm (tamoxifen + GDC-0032)in term of treatment safety and efficacy.
This study is an initiative of 3 academic partners (Cambridge University, Netherlands Cancer Institute and Vall d’Hebron Institute of Oncology (Barcelona)). The study drug (GDC-0032) is supplied by Genentech, Inc. a member of the Roche group.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/1045
Date of REC Opinion
6 Oct 2014
REC opinion
Further Information Favourable Opinion