Breast cancer (female) - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Royal Marsden NHS Foundation Trust

Recruitment countries:

United Kingdom

Health condition studied:

Breast Cancer

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: AZD 4547

Key inclusion and exclusion criteria:

• 
  Inclusion criteria
  
  - 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.
  
  - 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
  
  Exclusion criteria
  
  - 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
  
  - 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
  

• Age minimum: 25 Years
• Age maximum: N/A
• Gender: Both

Primary outcomes:

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 outcomes:

Disease control rate at eight weeks
Progression free survival
Response rate
Safety and tolerability of AZD4547

Target sample size:

48

Study type:

Interventional

Study design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts:

• Name: Angela Gillbanks
• Address:
• Phone: +44(0)2086613156
• Email: angela.gillbanks@rmh.nhs.uk
• Affiliation:

• Name: Angela Gillbanks
• Address:
• Phone: +44(0)2086613156
• Email: angela.gillbanks@rmh.nhs.uk
• Affiliation:

• Name: David Cunningham, MD FRCP
• Address:
• Phone:
• Email:
• Affiliation: Royal Marsden NHS Foundation Trust

Technical details

Scientific title:

Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

AstraZeneca

Main ID:

NCT01795768

Secondary ID:

3689

Register:

ClinicalTrials.gov

Date of registration:

31/01/2025

Date of first enrollment:

September 2012

Last refreshed:

19 February 2025