A Parp Inhibitor (BMN 673) for Inoperable Advanced eNDometrial cAncer
NCT ID: NCT02127151
Last Updated: 2021-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2014-10-01
2017-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMN 673
BMN 673 daily until progression, death, unacceptable toxicity, withdrawal of consent or any other criterion felt by the Investigator to preclude continuation of treatment.
BMN 673
Starting oral dose of 1.0 mg once daily to be taken until progression, death, unacceptable toxicity, withdrawal consent or any other criterion felt by the Investigator to preclude continuation of treatment.
Interventions
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BMN 673
Starting oral dose of 1.0 mg once daily to be taken until progression, death, unacceptable toxicity, withdrawal consent or any other criterion felt by the Investigator to preclude continuation of treatment.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed endometrial cancer. All histological subtypes except for carcinosarcoma are eligible
* Evidence of inoperable, advanced, recurrent or metastatic disease by imaging and/or histological criteria
* ≤ 1 previous line of systemic cancer therapy for inoperable, advanced, recurrent or metastatic endometrial cancer. Chemotherapy in the adjuvant setting is not considered a prior line of therapy unless recurrence occurred during adjuvant treatment or ≤ 6 months after the last treatment; first line treatment of advanced disease must include at least one cytotoxic agent to be considered as a line of therapy; prior hormonal treatment is not considered a line of therapy in any setting
* Written informed consent obtained prior to any screening procedures
* Patients must give consent for provision of archival histological tissue for the purposes of translational research. If archival tissue is not available or is of insufficient quantity and/or quality, the patient will have the option to consent to undergo biopsy where feasible. If biopsy is not feasible or the patient does not give consent for biopsy when archival tissue is not available, the patient will not be eligible for the trial. The quality and quantity of archival tissue will be assessed by a suitably qualified individual, usually a histopathologist, at site to ensure adequate tissue sample available for testing PTEN, MSI and MRE11
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
* Life expectancy ≥ 12 weeks
* Patient has at least one site of measurable disease on radiological imaging (i.e. target lesion) as per RECIST v1.1
* Evidence of non-childbearing status and must not be lactating OR must have postmenopausal status
* Adequate bone marrow and organ function
Exclusion Criteria
* Progressive disease ≤ 3 months after platinum-based chemotherapy
* Active uncontrolled infection including known Hepatitis B, Hepatitis C or HIV
* Obstruction of the gastrointestinal tract or other reason preventing effective oral administration of medication
* Serious concomitant non-malignant disease, uncontrolled organ dysfunction or medical disorder considered by the Investigator to make the subject unsuitable for trial participation including any psychiatric disorder that prevents informed consent
* Significant active cardiovascular disease
* Symptomatic brain metastases
* Immunosuppressant therapy or considered to be otherwise immunocompromised
* Myelodysplastic syndrome/acute myeloid leukaemia
* Major surgery ≤ 28 days prior to registration, or ongoing clinically significant post-surgical complications
* Chemotherapy, radiotherapy (a single fraction of palliative radiotherapy is allowed provided that the site being treated is not subsequently used as a target lesion as per RECIST v1.1 for the purpose of assessing tumour response on trial), immunotherapy or other investigational therapy for cancer ≤ 21 days prior to registration (42 days for nitrosoureas, mitomycin-C)
* Unresolved clinically significant toxicities from prior systemic therapy
* Known hypersensitivity to any of the agents or excipients to be administered
* Unwillingness or inability to comply with the trial protocol
* Patients with a history of other malignancy ≤ 3 years prior to registration with the exceptions of a) cone-biopsied in situ carcinoma of the cervix uteri; b) basal or squamous cell carcinoma of the skin.
18 Years
FEMALE
No
Sponsors
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Medivation, Inc.
INDUSTRY
University College, London
OTHER
Responsible Party
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Principal Investigators
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Rebecca Kristeleit
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, Greater Glasgow, United Kingdom
St Bartholomew's Hospital
London, Greater London, United Kingdom
University College Hospital
London, Greater London, United Kingdom
The Christie Hospital
Manchester, Greater Manchester, United Kingdom
Western General Hospital
Edinburgh, Lothian, United Kingdom
The Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Velindre Cancer Centre
Cardiff, South Glamorgan, United Kingdom
St James's University Hospital
Leeds, South Yorkshire, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, Surrey, United Kingdom
The Clatterbridge Cancer Centre
Bebington, Wirral, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
East Kent Hospitals University NHS Foundation Trust
Kent, , United Kingdom
Guy's Hospital
London, , United Kingdom
The Royal Marsden Hospital (London and Surrey)
London and Surrey, , United Kingdom
Northern Centre for Cancer Care
Newcastle, , United Kingdom
Countries
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Related Links
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Trial page on the University College London (UCL) Cancer Trials Centre website
Other Identifiers
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2013-003469-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UCL/13/0045
Identifier Type: -
Identifier Source: org_study_id
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