Endometrial CancerPhase 2PANDANCT02127151
A Parp Inhibitor (BMN 673) for Inoperable Advanced eNDometrial cAncer
A Phase 2 study testing BMN 673 in people with Endometrial Cancer, run by University College, London at 16 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- BMN 673
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- 1 Oct 2014to 1 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- 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
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- 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
Who cannot join
- Prior treatment with a poly adenosine diphosphate ribose polymerase (PARP) inhibitor
- 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
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United Kingdom16 sites
The Clatterbridge Cancer Centre
Bebington, Wirral, CH63 4JY
Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Velindre Cancer Centre
Cardiff, South Glamorgan, CF14 2TL
Western General Hospital
Edinburgh, Lothian, EH4 2XU
The Beatson West of Scotland Cancer Centre
Glasgow, Greater Glasgow, G12 0YN
East Kent Hospitals University NHS Foundation Trust
Kent
St James's University Hospital
Leeds, South Yorkshire, LS9 7TF
St Bartholomew's Hospital
London, Greater London, EC1A 7BE
University College Hospital
London, Greater London, NW1 2BU
Guy's Hospital
London, SE1 9RT
The Royal Marsden Hospital (London and Surrey)
London and Surrey
The Christie Hospital
Manchester, Greater Manchester, M20 4BX
Northern Centre for Cancer Care
Newcastle, NE7 7DN
The Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
Royal Marsden Hospital (Sutton)
Sutton, Surrey, SM2 5PT
About this study
Official title: A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With Retrospective PTEN, MSI and MRE11 Analysis
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
Read more
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.
- Conditions
- Endometrial Cancer
- Being tested
- BMN 673
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMN 673Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| BMN 673 | Experimental | BMN 673 daily until progression, death, unacceptable toxicity, withdrawal of consent or any other criterion felt by the Investigator to preclude continuation of treatment. Receives: Drug: BMN 673 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) rate
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.
Measured: 6 months
Secondary outcomes (6)
Best Response
Measured from the date of first BMN 673 dose.
Measured: Up to 30 months
Overall survival (OS)
Measured: Up to 30 months
Response at each radiological assessment
Measured: Up to 30 months
Duration of Response (DoR)
Measured: Up to 30 months
Median PFS
Measured: Up to 30 months
Safety and toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 3-4 toxicity; dose reductions, omissions, delays; exposure; compliance.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study start1 Oct 2014
- Primary completion1 May 2017
- Study completion1 May 2017
Why it stopped: Withdrawal of Industry support for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Rebecca Kristeleit, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127151
- Sponsor's protocol ID
- UCL/13/0045
- Other IDs
- 2013-003469-32
- Acronym
- PANDA
- Status last verified
- Aug 2021
- First submitted
- 14 Apr 2014
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With Retrospective PTEN, MSI and MRE11 Analysis
- ClinicalTrials.gov ID
- NCT02127151
- Acronym / sponsor ID
- PANDA / UCL/13/0045
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of Industry support for the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Medivation, Inc.
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMN 673 | Experimental | Drug: BMN 673BMN 673 daily until progression, death, unacceptable toxicity, withdrawal of consent or any other criterion felt by the Investigator to preclude continuation of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- 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
Key exclusion criteria (15 listed)
- Prior treatment with a poly adenosine diphosphate ribose polymerase (PARP) inhibitor
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMN 673Starting 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. | Drug | BMN 673 |
Primary outcome
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.
6 secondary outcomes
Best Response
Time frame: Up to 30 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Kristeleit principal investigator
University College, London
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMN 673 in people with Endometrial Cancer, run by University College, London at 16 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.