Gastric CancerPhase 2FGFRNCT01795768
Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours
A Phase 2 study testing AZD 4547 in people with Gastric Cancer and Oesophageal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2 amplified breast, squamous lung and stomach cancer whose cancers have progressed following previous chemotherapy Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Gastric Cancer, Oesophageal Cancer, Breast Cancer
- What is being tested?
- AZD 4547
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Sep 2015
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged 25 years or older.
- Mandatory provision of archival or fresh tumour biopsy for confirmation of FGFR gene amplification.
- World Health Organisation performance status 0-2, minimum life expectancy of 12 weeks from proposed first dose date
- Patient ability to comply with the collection of tumor biopsies which is mandatory at baseline and on days 10-14
- Calcium and phosphate within normal limits.
- At least one lesion, not previously irradiated, that can be accurately measured at baseline as >=10 mm in the longest diameter - except lymph nodes which must have short axis >=15 mm.
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- Local disease confined to the stomach or oesophagus is not considered measurable (patients with locally advanced gastro-oesophageal adenocarcinoma must have at least one measurable nodal lesion >=15mm in the short axis).
- Tumour specific inclusion criteria
- Advanced gastro-oesophageal adenocarcinoma
- Histologically proven metastatic or locally advanced inoperable adenocarcinoma of the stomach, lower oesophagus or oesophago-gastric junction.
- Documented progression after 1 or 2 prior courses of chemotherapy for advanced disease,
- FGFR2 amplification
- Advanced breast carcinoma
- Histologically confirmed metastatic or locally advanced breast cancer, negative for HER2 as determined by local laboratory.
- Patients with locally advanced disease must have recurrent, or progressive, disease that is not suitable for treatment with curative intent
- Patients with ER positive disease must have been treated with at least one line of hormonal therapy for recurrent/progressive disease or have been on hormonal therapy at the time of recurrence/progression
- Documented progression after at least one and no more than three prior courses of chemotherapy for advanced disease.
- FGFR1 amplification
- Advanced squamous cell lung cancer
- Histologically confirmed metastatic or locally advanced squamous cell carcinoma of lung
- Documented progression after 1 or 2 prior courses of chemotherapy for advanced disease
- FGFR1 amplification
Who cannot join
- Treatment potent inhibitors or inducers of CYP3A4, 2C8 or 2D6 or substrates of CYP3A4 within specified durations prior to the first dose of study treatment
- Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks before the first dose of study treatment
- Prior exposure to AZD4547 or any other drug with FGFR inhibition as its primary mode of action
- Untreated brain metastases
- Inadequate bone marrow reserve or organ function
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- Corrected total calcium > ULN
- Total phosphate > ULN
- Mean resting corrected QT interval > 470 msec obtained from 3 consecutive electrocardiograms (ECGs)
- Any of the following ophthalmological criteria: 1)Current evidence or previous history of retinal pigmented epithelium detachment (RPED). 2)Previous laser treatment or intra-ocular injection for treatment of macular degeneration. 3) Current evidence or previous history of dry or wet age-related macular degeneration. 4) Current evidence or previous history of retinal vein occlusion (RVO). 5) Current evidence or previous history of retinal degenerative diseases (e.g. hereditary). 6) Current evidence or previous history of any other clinically relevant chorioretinal defect
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
London and Surrey, Surrey, SM2 5PT
Angela Gillbanks, +44(0)2086613156, angela.gillbanks@rmh.nhs.uk
David Cunningham, MD FRCP
About this study
To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2 amplified breast, squamous lung and stomach cancer whose cancers have progressed following previous chemotherapy
Read the detailed description
Primary endpoint
- To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
Secondary endpoints
- Objective response rate to AZD4547 in all patients and in each tumour group
- Safety and tolerability of AZD4547 in all patients
- Disease control rate at 8 weeks
- Progression free survival in all patients and in each tumour group
- Being tested
- AZD 4547
- Keywords
- Non randomised, Open label, Multicentre, Phase II biomarker study
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD 4547Drug
| Study group | Role | What they receive |
|---|---|---|
| Single Treatment Arm | Experimental | 16-24 patients per tumour group will be treated with AZD4547 administered 80mg twice daily, 2 weeks on, 1 week off in 21 days cycles. Receives: Drug: AZD 4547 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
A primary objective of the study is to collect serial research biopsies at baseline and on treatment with AZD4547, to assess the molecular changes that occur in the tumour in response to AZD4547 treatment and correlate with change in tumour size assessed at 8 weeks.
Measured: Baseline (tumour size, pERK), day 14(pERK), and week 8(tumour size)
Secondary outcomes (4)
Response rate
Response rate is assessed using RECIST 1.1 radiological response and centrally reviewed.
Measured: Eight weeks from treatment initiation and then every 6 weeks thereafter
Progression free survival
Measured: Time measured from baseline to disease progression or death from any cause (approximately 3-9 months)
Disease control rate at eight weeks
Measured: Disease control rate will be calculated as the proportion of patients with CR/PR/SD at eight weeks from baseline
Safety and tolerability of AZD4547
Measured: Toxicity is assessed from consent until 30 days following treatment cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- David Cunningham, MD FRCP, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795768
- Sponsor's protocol ID
- 3689
- Acronym
- FGFR
- Status last verified
- Mar 2013
- First submitted
- 31 Jan 2013
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours
- ClinicalTrials.gov ID
- NCT01795768
- Acronym / sponsor ID
- FGFR / 3689
- Keywords
- Non randomised, Open label, Multicentre, Phase II biomarker study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 21 Feb 2013 (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.
To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2 amplified breast, squamous lung and stomach cancer whose cancers have progressed following previous chemotherapy
Detailed description
Primary endpoint
- To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
Secondary endpoints
- Objective response rate to AZD4547 in all patients and in each tumour group
- Safety and tolerability of AZD4547 in all patients
- Disease control rate at 8 weeks
- Progression free survival in all patients and in each tumour group
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Treatment Arm | Experimental | Drug: AZD 454716-24 patients per tumour group will be treated with AZD4547 administered 80mg twice daily, 2 weeks on, 1 week off in 21 days cycles. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female or male aged 25 years or older.
- Mandatory provision of archival or fresh tumour biopsy for confirmation of FGFR gene amplification.
- World Health Organisation performance status 0-2, minimum life expectancy of 12 weeks from proposed first dose date
- Patient ability to comply with the collection of tumor biopsies which is mandatory at baseline and on days 10-14
- Calcium and phosphate within normal limits.
Key exclusion criteria (10 listed)
- Treatment potent inhibitors or inducers of CYP3A4, 2C8 or 2D6 or substrates of CYP3A4 within specified durations prior to the first dose of study treatment
- Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks before the first dose of study treatment
- Prior exposure to AZD4547 or any other drug with FGFR inhibition as its primary mode of action
- Untreated brain metastases
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 |
|---|---|---|
| AZD 4547 | Drug | Single Treatment Arm |
Primary outcome
To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
Time frame: Baseline (tumour size, pERK), day 14(pERK), and week 8(tumour size)
A primary objective of the study is to collect serial research biopsies at baseline and on treatment with AZD4547, to assess the molecular changes that occur in the tumour in response to AZD4547 treatment and correlate with change in tumour size assessed at 8 weeks.
4 secondary outcomes
Response rate
Time frame: Eight weeks from treatment initiation and then every 6 weeks thereafter
Progression free survival
Time frame: Time measured from baseline to disease progression or death from any cause (approximately 3-9 months)
Disease control rate at eight weeks
Time frame: Disease control rate will be calculated as the proportion of patients with CR/PR/SD at eight weeks from baseline
Safety and tolerability of AZD4547
Time frame: Toxicity is assessed from consent until 30 days following treatment cessation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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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.
David Cunningham, MD FRCP principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD 4547 in people with Gastric Cancer and Oesophageal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site 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 22 inclusion and 10 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Gillbanks (+44(0)2086613156, angela.gillbanks@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14. (time frame: Baseline (tumour size, pERK), day 14(pERK), and week 8(tumour size)). 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 15 Mar 2013.