A Parp Inhibitor (BMN 673) for Inoperable Advanced eNDometrial cAncer
Status:
Withdrawn
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With
Retrospective PTEN, MSI and MRE11 Analysis
PTEN= Phosphatase and tensin homolog MSI= Microsatellite instability MRE11= Double-strand
break repair protein MRE11A
This trial will investigate whether the drug BMN 673 has therapeutic benefit in the treatment
of advanced endometrial cancer. Nearly 8,000 patients are diagnosed with endometrial cancer
in the UK every year. A significant proportion are either diagnosed with advanced disease
which may be inoperable and/or metastatic (i.e spread to other organs outside the
endometrium), or curable disease which relapses following first line treatment. There is no
established standard of care for these patients as both chemo and hormone therapy has limited
effectiveness and survival benefit. Survival rates have not improved in the past 20 years.
Furthermore there are no so called 'targeted' drugs licensed for its treatment i.e. drugs
that block the growth and spread of cancer by interfering with specific molecules involved in
tumor growth and progression. This leaves an unmet need for effective systemic treatments for
advanced, inoperable and metastatic endometrial cancer.
BMN 673 has been shown to be potentially effective in treating cancers known to behave
similarly to endometrial disease, 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 that
might lead to a new effective treatment for patients with inoperable, advanced, recurrent or
metastatic endometrial cancer, while the proposed substudy also presents the possibility of
discovering a subset of patients more likely to derive benefit from BMN 673.
This trial is for adult women (18 and above) with advanced, inoperable or metastatic
endometrial cancer. Patients will be recruited from approximately 15 National Health Service
(NHS) Trusts based in the United Kingdom (UK). The study is expected to last approximately
18-24 months in terms of recruitment time, and a maximum of 100 eligible women will be
registered. All patients will receive BMN 673 until their disease worsens or their doctor
decides they should stop treatment.