NeoplasmsPhase 2FURVANCT02530411
Fulvestrant +/- Vandetanib in Advanced Aromatase Inhibitor Resistant Breast Cancer
A Phase 2 study testing Fulvestrant and Vandetanib in people with Neoplasms, run by Velindre NHS Trust at 5 sites in United Kingdom.
Trial summary
A randomised double blind placebo controlled phase II study of fulvestrant with or without the addition of vandetanib as treatment for patients with metastatic breast cancer resistant to aromatase inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms
- What is being tested?
- Fulvestrant and Vandetanib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Apr 2015to Dec 2020
- 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
- Female ≥ 18 years
- Post-menopausal
- Minimum life expectancy 12 weeks
- Histological confirmation of ER+ve breast cancer on primary tumour at diagnosis/on biopsy of metastasis
- Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis/on biopsy of a metastasis
- Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection
Show all 17Show fewer
- ECOG 0-2 with no deterioration over previous 2 weeks
- Measurable or non-measurable disease
- Adequate bone marrow and organ function
- Progressive disease whilst receiving third generation aromatase inhibitor for locally advanced or metastatic BC or relapsed with metastatic disease whilst receiving third generation AI in adjuvant setting
- Radiological or objective clinical evidence of recurrence or progression on or after last systemic therapy prior to enrolment
- ≤3 prior lines of endocrine therapy for ABC
- ≤ 1 line of cytotoxic chemotherapy for ABC
- Suitable for further endocrine therapy
- Availability of archival tumour sample or fresh biopsy
- Informed consent
- Normal cardiac function
Who cannot join
- Previous treatment with fulvestrant or inhibitors of RET pathway
- Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days (<6 weeks for nitrosurea or mitomycin C) prior to study treatment
- Last dose of palliative radiotherapy <7 days prior to study treatment
- Rapidly progressive visceral disease not suitable for further endocrine therapy
- Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
- Any of the following cardiac criteria: Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2 within 12 weeks before randomisation, or presence of cardiac disease that increases risk of ventricular arrhythmia; History of arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia; Congenital long QT syndrome; History of QT prolongation associated with other medications that required discontinuation of that medication; QTcB >480msec on screening ECG
Show all 16Show fewer
- Electrolyte values: Potassium <4.0 mmol/L despite supplementation, or above CTCAE Grade 1 upper limit, at randomisation; Magnesium below the normal range despite supplementation, or above CTCAE Grade 1 upper limit, at randomisation; Calcium (ionised or serum) below the normal range despite supplementation, or above Grade 1 upper limit, at randomisation
- Creatinine clearance <30 ml/min. Patients with creatinine clearance <50 mL/min will start at a permanently reduced vandetanib dose of 200 mg.
- Major surgery (excluding placement of vascular access) within 4 weeks before study treatment
- Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
- With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
- Elevated ALP in absence of bone metastasis
- History of hypersensitivity to active or inactive excipients of vandetanib or fulvestrant
- Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
- Participation in another study with investigational product during last 30 days
- Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
Royal United Hospital Bath
Bath, BA1 3NG
Mark Beresford, MD MRCP FRCR, 01225 824797, mark.beresford@nhs.net
- Recruiting
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
Tamas Hickish, MA MD FRCP, 01202 704789, tamashickish@rbch.nhs.uk
- Recruiting
Velindre Cancer Center, Velindre Hospital
Cardiff, Wales, CF14 2TL
Robert Jones, MD PhD MCRCP, 029 2061 5888, robert.jones14@wales.nhs.uk
- Recruiting
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Anne Hong, MB ChB MRCP, 01392 402118, anne.hong@nhs.net
- Recruiting
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
Duncan Wheatley, MBBS, FRCR, 01872 258304, duncan.wheatley@rcht.cornwall.nhs.uk
About this study
Official title: A Randomised Double Blind Placebo Controlled Phase II Study of Fulvestrant With or Without the Addition of Vandetanib as Treatment for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy
A randomised double blind placebo controlled phase II study of fulvestrant with or without the addition of vandetanib as treatment for patients with metastatic breast cancer resistant to aromatase inhibitor therapy.
Read the detailed description
For patients with advanced breast cancer that has spread around the body, hormone therapy is often the best treatment. As well as being very effective, this means that patients do not experience the toxicity and inconvenience of chemotherapy. However, eventually the cancer is likely to become resistant to hormone therapy and in this situation, although other hormone drugs can be used, they sometimes do not work very well. So it is important to find ways of getting the cancer to respond to hormone treatment again.
There are many different ways in which breast cancer cells become resistant to hormone treatments, including a 'signalling' pathway in the cells called RET [Receptor tyrosine kinase RET] REarranged during Transfection. Research has shown increased activity of RET signalling pathways in hormone resistant cancer cells.
Vandetanib is an oral drug that inhibits RET signalling in cells and has been shown in laboratory studies to prevent the growth of breast cancer cells which have become resistant to hormone therapy. Hormone therapy drugs include tamoxifen, and the aromatase inhibitors (anastrozole, letrozole and exemestane). The investigators therefore believe that giving vandetanib together with hormone therapy may help prevent resistance to treatment in patients with breast cancer. In this trial the investigators will combine this drug with fulvestrant, another hormone therapy drug which is sometimes used alone in patients who have developed resistance to aromatase inhibitors, or tamoxifen. So patients entering the trial will have one drug, fulvestrant, which is known to work and may also be given the experimental drug, vandetanib.
To properly determine if vandetanib works as the investigators believe, this study will compare the activity of vandetanib combined with fulvestrant with fulvestrant combined with an inactive, 'placebo' tablet in a group of patients for whom treatment with single agent fulvestrant is thought appropriate. The investigators plan to recruit a total of 160 patients. Half of them will be given fulvestrant and vandetanib and half will be given fulvestrant and placebo, and the treatment a particular patient will get will be chosen by random chance. Neither the patient nor the patients doctor will know whether the patient is getting vandetanib or the inactive placebo. The most important measure of effect will be the time until the cancer grows again, but the study will also look closely at the side effects of the drugs. The investigators will also look at whether the way in which an individual responds relates to the results from laboratory studies on the RET pathways carried out on previously stored tumour samples. This will mean that patients will not need to have additional biopsy samples taken.
- Conditions
- Neoplasms
- Being tested
- Fulvestrant, Vandetanib
- Keywords
- Hormone resistance, vandetanib, fulvestrant
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called FASLODEX™ (also previously known as ZD9238)
The pharmacology and mode of action studies established that fulvestrant is the first agent in a new class of anti-estrogens that down-regulate the estrogen receptor (ER), and can therefore be described as an ER down-regulator.
VandetanibDrug
Also called CAPRELSA™ (also previously known as ZACTIMA™, ZD6474)
Vandetanib is a potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptor (VEGFR; also known as kinase insert domain containing receptor)-2, an endothelial cell receptor for vascular endothelial growth factor (VEGF), and also possesses activity against epidermal growth factor receptor (EGFR) and Rearranged during Transfection (RET) tyrosine kinases.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Fulvestrant 500mg Intra Muscular (IM) Day 1 (D1), D15, then D1 of every 28 day cycle Vandetanib 300 mg Per os (po) daily Clinician review D1, D15, weeks 4, 8, 12, 16, 20, 24 then 12 weekly. Computerised Axial Tomography (CT) at week 8, 16, 24 then 12 weekly. Receives: Drug: Fulvestrant; Drug: Vandetanib |
| Control | Placebo comparator | Fulvestrant 500mg IM D1, D15, then D1 of every 28 day cycle Placebo po daily Clinician review D1, D15, weeks 4, 8, 12, 16, 20, 24 then 12 weekly. CT at week 8, 16, 24 then 12 weekly. Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time to event based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. - Time from randomisation to any disease progression and/or death.
Measured: Time to event. This outcome will be assessed over an estimated period of up to 45 months.
Secondary outcomes (6)
Objective Response Rate
Objective Response Rate as assessed by the Response Evaluation Criteria in Solid Tumours (RECIST). Disease progression will be formally assessed according to the RECIST v1.1 criteria.
Measured: Time to event. This outcome will be assessed when all participants have completed a minimum 12 months follow-up and at least 98 disease progression events are observed, i.e. over an estimated period of up to 45 months.
Overall Survival
Time from enrolment to death from any cause with those still alive censored at date last seen.
Measured: Time to event. This outcome will be assessed over an estimated period of up to 45 months.
Exploratory analysis: The influence of RET signalling pathway components expression on vandetanib activity.
The influence of RET signalling pathway components expression on vandetanib activity.
Measured: Data will be analysed when archival tumour tissue samples have been collected from all consenting patients. This outcome will be assessed and data presented up to 45 months.
Safety and tolerability of the fulvestrant/vandetanib trial drug regime measured by the number of participants with reported serious adverse events (composite outcome measure).
This outcome will observe the number of side effects of the combined vandetanib and fulvestrant drug regime as recorded via real-time serious adverse event reporting.
Measured: Initial safety reviews will be conducted after 20 and 40 patients have completed at least one cycle of treatment (estimated 8 and 16 months after enrolment of the first patient respectively). Final assessment/data presentation by 2018 (up to 45 months).
Feasibility of use of the combined vandetanib/fulvestrant trial drug regime measured by the number of participants requiring dose delays, reductions and/or study withdrawal to manage reported serious adverse events.
This outcome will assess the number of patients requiring dose delays, reductions, and/or study withdrawal to manage side effects recorded via real-time serious adverse event reporting.
Measured: Initial safety reviews will be conducted after 20 and 40 patients have completed at least one cycle of treatment (estimated 8 and 16 months after enrolment of the first patient respectively). Final assessment/data presentation by 2018 (up to 45 months).
Clinical Benefit Rate (measuring the proportion of patients with no disease progression after six months of treatment)
The clinical benefit rate will be assessed by measuring the proportion of patients with no disease progression after six months of treatment. Disease progression will be formally assessed according to the RECIST v1.1 criteria.
Measured: The trial data will be analysed when all participants have completed a minimum 12 months follow-up and at least 98 disease progression events are observed. This outcome will be assessed and the data presented up to 45 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Velindre NHS Trust
- Sponsor type
- Other government
- Collaborators
- Cancer Research UK, AstraZeneca
- Responsible party
- Principal investigator, Lisette Nixon, Velindre NHS Trust
- Investigators
- Mark Beresford, MD MRCP FRCR, Study director, Royal United Hospital NHS Trust, Bath, UKRobert Jones, MD PhD MCRCP, Study director, Velindre NHS Trust, Cardiff, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530411
- Sponsor's protocol ID
- 2014/VCC/0013
- Other IDs
- 2014-001208-23, 2014
- Acronym
- FURVA
- Status last verified
- Aug 2015
- First submitted
- 23 Mar 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beresford M, Casbard A, Hudson Z, Carucci M, Ingarfield K, Gee J, Smith J, Kitson T, Alchami F, Madden TA, Hayward L, Hwang D, Spensley S, Waters S, Wheatley D, Jones RH. Fulvestrant plus vandetanib versus placebo for the treatment of patients with metastatic breast cancer resistant to aromatase inhibitor therapy (FURVA): a multicentre, Phase 2, randomised controlled trial. BJC Rep. 2023 Sep 14;1(1):13. doi: 10.1038/s44276-023-00016-8.
PubMed 39516358
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blind Placebo Controlled Phase II Study of Fulvestrant With or Without the Addition of Vandetanib as Treatment for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT02530411
- Acronym / sponsor ID
- FURVA / 2014/VCC/0013
- Conditions
- Neoplasms
- Keywords
- Hormone resistance, vandetanib, fulvestrant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Velindre NHS TrustOther government
- Collaborators
- Cancer Research UK, AstraZeneca
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Aug 2015 (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 randomised double blind placebo controlled phase II study of fulvestrant with or without the addition of vandetanib as treatment for patients with metastatic breast cancer resistant to aromatase inhibitor therapy.
Detailed description
For patients with advanced breast cancer that has spread around the body, hormone therapy is often the best treatment. As well as being very effective, this means that patients do not experience the toxicity and inconvenience of chemotherapy. However, eventually the cancer is likely to become resistant to hormone therapy and in this situation, although other hormone drugs can be used, they sometimes do not work very well. So it is important to find ways of getting the cancer to respond to hormone treatment again.
There are many different ways in which breast cancer cells become resistant to hormone treatments, including a 'signalling' pathway in the cells called RET [Receptor tyrosine kinase RET] REarranged during Transfection. Research has shown increased activity of RET signalling pathways in hormone resistant cancer cells.
Vandetanib is an oral drug that inhibits RET signalling in cells and has been shown in laboratory studies to prevent the growth of breast cancer cells which have become resistant to hormone therapy. Hormone therapy drugs include tamoxifen, and the aromatase inhibitors (anastrozole, letrozole and exemestane). The investigators therefore believe that giving vandetanib together with hormone therapy may help prevent resistance to treatment in patients with breast cancer. In this trial the investigators will combine this drug with fulvestrant, another hormone therapy drug which is sometimes used alone in patients who have developed resistance to aromatase inhibitors, or tamoxifen. So patients entering the trial will have one drug, fulvestrant, which is known to work and may also be given the experimental drug, vandetanib.
To properly determine if vandetanib works as the investigators believe, this study will compare the activity of vandetanib combined with fulvestrant with fulvestrant combined with an inactive, 'placebo' tablet in a group of patients for whom treatment with single agent fulvestrant is thought appropriate. The investigators plan to recruit a total of 160 patients. Half of them will be given fulvestrant and vandetanib and half will be given fulvestrant and placebo, and the treatment a particular patient will get will be chosen by random chance. Neither the patient nor the patients doctor will know whether the patient is getting vandetanib or the inactive placebo. The most important measure of effect will be the time until the cancer grows again, but the study will also look closely at the side effects of the drugs. The investigators will also look at whether the way in which an individual responds relates to the results from laboratory studies on the RET pathways carried out on previously stored tumour samples. This will mean that patients will not need to have additional biopsy samples taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Fulvestrant, Drug: VandetanibFulvestrant 500mg Intra Muscular (IM) Day 1 (D1), D15, then D1 of every 28 day cycle Vandetanib 300 mg Per os (po) daily Clinician review D1, D15, weeks 4, 8, 12, 16, 20, 24 then 12 weekly. Computerised Axial Tomography (CT) at week 8, 16, 24 then 12 weekly. |
| Control | Placebo comparator | Drug: FulvestrantFulvestrant 500mg IM D1, D15, then D1 of every 28 day cycle Placebo po daily Clinician review D1, D15, weeks 4, 8, 12, 16, 20, 24 then 12 weekly. CT at week 8, 16, 24 then 12 weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female ≥ 18 years
- Post-menopausal
- Minimum life expectancy 12 weeks
- Histological confirmation of ER+ve breast cancer on primary tumour at diagnosis/on biopsy of metastasis
- Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis/on biopsy of a metastasis
Key exclusion criteria (16 listed)
- Previous treatment with fulvestrant or inhibitors of RET pathway
- Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days (<6 weeks for nitrosurea or mitomycin C) prior to study treatment
- Last dose of palliative radiotherapy <7 days prior to study treatment
- Rapidly progressive visceral disease not suitable for further endocrine therapy
- Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
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 |
|---|---|---|
| FulvestrantAlso: FASLODEX™ (also previously known as ZD9238)The pharmacology and mode of action studies established that fulvestrant is the first agent in a new class of anti-estrogens that down-regulate the estrogen receptor (ER), and can therefore be described as an ER down-regulator. | Drug | Control, Experimental |
| VandetanibAlso: CAPRELSA™ (also previously known as ZACTIMA™, ZD6474)Vandetanib is a potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptor (VEGFR; also known as kinase insert domain containing receptor)-2, an endothelial cell receptor for vascular endothelial growth factor (VEGF), and also possesses activity against epidermal growth factor receptor (EGFR) and Rearranged during Transfection (RET) tyrosine kinases. | Drug | Experimental |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Time to event. This outcome will be assessed over an estimated period of up to 45 months.
Time to event based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. - Time from randomisation to any disease progression and/or death.
6 secondary outcomes
Objective Response Rate
Time frame: Time to event. This outcome will be assessed when all participants have completed a minimum 12 months follow-up and at least 98 disease progression events are observed, i.e. over an estimated period of up to 45 months.
Overall Survival
Time frame: Time to event. This outcome will be assessed over an estimated period of up to 45 months.
Exploratory analysis: The influence of RET signalling pathway components expression on vandetanib activity.
Time frame: Data will be analysed when archival tumour tissue samples have been collected from all consenting patients. This outcome will be assessed and data presented up to 45 months.
Safety and tolerability of the fulvestrant/vandetanib trial drug regime measured by the number of participants with reported serious adverse events (composite outcome measure).
Time frame: Initial safety reviews will be conducted after 20 and 40 patients have completed at least one cycle of treatment (estimated 8 and 16 months after enrolment of the first patient respectively). Final assessment/data presentation by 2018 (up to 45 months).
Feasibility of use of the combined vandetanib/fulvestrant trial drug regime measured by the number of participants requiring dose delays, reductions and/or study withdrawal to manage reported serious adverse events.
Time frame: Initial safety reviews will be conducted after 20 and 40 patients have completed at least one cycle of treatment (estimated 8 and 16 months after enrolment of the first patient respectively). Final assessment/data presentation by 2018 (up to 45 months).
Clinical Benefit Rate (measuring the proportion of patients with no disease progression after six months of treatment)
Time frame: The trial data will be analysed when all participants have completed a minimum 12 months follow-up and at least 98 disease progression events are observed. This outcome will be assessed and the data presented up to 45 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Derived from this study: PubMed 39516358Beresford M, Casbard A, Hudson Z, Carucci M, Ingarfield K, Gee J, Smith J, Kitson T, Alchami F, Madden TA, Hayward L, Hwang D, Spensley S, Waters S, Wheatley D, Jones RH. Fulvestrant plus vandetanib versus placebo for the treatment of patients with metastatic breast cancer resistant to aromatase inhibitor therapy (FURVA): a multicentre, Phase 2, randomised controlled trial. BJC Rep. 2023 Sep 14;1(1):13. doi: 10.1038/s44276-023-00016-8.
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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.
Mark Beresford, MD MRCP FRCR study director
Royal United Hospital NHS Trust, Bath, UK
Robert Jones, MD PhD MCRCP study director
Velindre NHS Trust, Cardiff, UK
5 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 Fulvestrant and Vandetanib in people with Neoplasms, run by Velindre NHS Trust at 5 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 17 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna Smith, BSc MSc PhD (029 20687500, sealjd@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Time to event. This outcome will be assessed over an estimated period of up to 45 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530411, which also lists 1 linked publication.
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 21 Aug 2015.