A Parp Inhibitor (BMN 673) for Inoperable Advanced eNDometrial cAncer (PANDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02127151|
Recruitment Status : Withdrawn (Withdrawal of Industry support for the study)
First Posted : April 30, 2014
Last Update Posted : December 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: BMN 673||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With Retrospective PTEN, MSI and MRE11 Analysis|
|Estimated Primary Completion Date :||October 2018|
Experimental: 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.
Drug: 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.
- Progression free survival (PFS) rate [ Time Frame: 6 months ]Measured from date of first BMN 673 dose to first progression (defined using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1) or death, whichever is the sooner.
- Best Response [ Time Frame: Up to 30 months ]Measured from the date of first BMN 673 dose.
- Overall survival (OS) [ Time Frame: Up to 30 months ]
- Response at each radiological assessment [ Time Frame: Up to 30 months ]
- Duration of Response (DoR) [ Time Frame: Up to 30 months ]
- Median PFS [ Time Frame: Up to 30 months ]
- Safety and toxicity [ Time Frame: Up to 30 months ]Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 3-4 toxicity; dose reductions, omissions, delays; exposure; compliance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127151
|Royal Sussex County Hospital|
|Brighton, East Sussex, United Kingdom, BN2 5BE|
|The Beatson West of Scotland Cancer Centre|
|Glasgow, Greater Glasgow, United Kingdom, G12 0YN|
|St Bartholomew's Hospital|
|London, Greater London, United Kingdom, EC1A 7BE|
|University College Hospital|
|London, Greater London, United Kingdom, NW1 2BU|
|The Christie Hospital|
|Manchester, Greater Manchester, United Kingdom, M20 4BX|
|Western General Hospital|
|Edinburgh, Lothian, United Kingdom, EH4 2XU|
|The Churchill Hospital|
|Oxford, Oxfordshire, United Kingdom, OX3 7LE|
|Velindre Cancer Centre|
|Cardiff, South Glamorgan, United Kingdom, CF14 2TL|
|St James's University Hospital|
|Leeds, South Yorkshire, United Kingdom, LS9 7TF|
|Royal Marsden Hospital (Sutton)|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|The Clatterbridge Cancer Centre|
|Bebington, Wirral, United Kingdom, CH63 4JY|
|Bristol Haematology and Oncology Centre|
|Bristol, United Kingdom, BS2 8ED|
|East Kent Hospitals University NHS Foundation Trust|
|Kent, United Kingdom|
|The Royal Marsden Hospital (London and Surrey)|
|London and Surrey, United Kingdom|
|London, United Kingdom, SE1 9RT|
|Northern Centre for Cancer Care|
|Newcastle, United Kingdom, NE7 7DN|
|Principal Investigator:||Rebecca Kristeleit||University College, London|