PANDA
Research type
Research Study
Full title
A Single Arm Phase II trial of BMN 673 for inoperable, advanced endometrial cancer with retrospective PTEN, MSI and MRE11 analysis.
IRAS ID
139201
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
University College London
Eudract number
2013-003469-32
Clinicaltrials.gov Identifier
Research summary
This trial will investigate whether the drug BMN 673 has therapeutic benefit in the treatment of inoperable, advanced, recurrent or metastatic endometrial cancer. Over 8,000 patients are diagnosed with endometrial cancer in the UK every year. A significant proportion are either diagnosed with advanced cancer which is inoperable and/or metastatic (i.e. has spread to other organs), or curable cancer which recurs (relapses) following first line treatment. There is no established standard of care for these patients: chemotherapy and hormone therapy have limited effectiveness. Survival rates have not improved in the past 20 years. Furthermore there are no 'targeted' drugs licensed for its treatment i.e. drugs that block the growth and spread of cancer by interfering with specific molecules involved in tumour growth. This leaves an unmet need for effective systemic treatments in women with these forms of endometrial cancer.
BMN 673 has been shown to be potentially effective in treating cancers known to behave similarly to endometrial cancer, both in the laboratory and in Phase I studies involving patients with advanced cancers. Similarly the drug appears to be relatively tolerable. A Phase II trial such as the one proposed by this application could demonstrate activity justifying further investigation of BMN 673 as a potential treatment for endometrial cancer. The proposed substudy presents the possibility of discovering a subset of patients more likely to derive benefit from BMN 673.
This trial is for adult women (= 18 years) with inoperable, advanced, recurrent or metastatic endometrial cancer. Patients will be recruited from approximately 12 NHS Trusts based in the UK. The study is expected to recruit for 18-24 months. A maximum of 100 eligible women will be registered. All patients will receive BMN 673 until the cancer significantly worsens or the patient and/or Investigator decides they should stop treatment.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/1564
Date of REC Opinion
13 Oct 2014
REC opinion
Further Information Favourable Opinion