Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
SHINE
A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.
1 other identifier
interventional
960
16 countries
61
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2011
Typical duration for phase_2
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 7, 2017
CompletedMarch 7, 2017
January 1, 2017
1.8 years
September 16, 2011
February 11, 2016
January 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Progression Free Survival
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).
Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)
Secondary Outcomes (4)
Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)
Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)
Objective Response Rate
Week 8 (±1 week) and then every 8 weeks (±1 week)
Percentage Change From Baseline at Week 8 in Target Lesion Size
Baseline, Week 8 (±1 week)
Percentage of Patients Without Progressive Disease at 8 Weeks
Week 8 (±1 week)
Study Arms (2)
AZD4547
EXPERIMENTALAZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule
Paclitaxel
ACTIVE COMPARATORPaclitaxel - 80mg/m² as a 1 hour infusion given weekly on days 1, 8 and 15 of a 28 day cycle (up to the maximum number of cycles per local practice)
Interventions
Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule.
Eligibility Criteria
You may qualify if:
- Female or male aged 25 or over
- Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
- Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
- At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
- Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
You may not qualify if:
- Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
- Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given \> 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
- With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade \>1 at the time of starting study treatment.
- Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (61)
Research Site
Brussels (Anderlecht), Belgium
Research Site
Brussels (Woluwé-St-Lambert), Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Vratsa, Bulgaria
Research Site
Fredericton, New Brunswick, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Brno, Czechia
Research Site
Olomouc, Czechia
Research Site
Prague, Czechia
Research Site
Saint-Cloud, France
Research Site
Villejuif, France
Research Site
Hamburg, Germany
Research Site
Mainz, Germany
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Bangalore, India
Research Site
Chennai, India
Research Site
Hyderabad, India
Research Site
Nagpur, India
Research Site
Pune, India
Research Site
Vellore, India
Research Site
Ancona, Italy
Research Site
Milan, Italy
Research Site
Pisa, Italy
Research Site
Roma, Italy
Research Site
Chiba, Japan
Research Site
Chūōku, Japan
Research Site
Kōtoku, Japan
Research Site
Nagoya, Japan
Research Site
Sapporo, Japan
Research Site
Takatsuki-shi, Japan
Research Site
Brasov, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Anyang-si, South Korea
Research Site
Daegu, South Korea
Research Site
Hwasun-gun, South Korea
Research Site
Jeonju, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Oviedo, Spain
Research Site
Santander, Spain
Research Site
Seville, Spain
Research Site
Keelung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan
Research Site
Kharkiv, Ukraine
Research Site
Lviv, Ukraine
Research Site
Aberdeen, United Kingdom
Research Site
London, United Kingdom
Research Site
Maidstone, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Sutton, United Kingdom
Research Site
Wolverhampton, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Prompted by slow recruitment, AZ and the SRC instigated unscheduled analysis of the efficacy and tolerability. It was concluded that the study was unlikely to meet its primary objective. Enrolment ceased and the study closed.
Results Point of Contact
- Title
- Donal Landers
- Organization
- Astrazeneca
Study Officials
- STUDY DIRECTOR
Paul Stockman, MD PHD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Eric Van Cutsem, MD PHD
University Hospital, Gasthuisberg
- PRINCIPAL INVESTIGATOR
Yung-Jue Bang, MD, PHD
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
October 24, 2011
Study Start
November 1, 2011
Primary Completion
August 1, 2013
Study Completion
February 1, 2015
Last Updated
March 7, 2017
Results First Posted
March 7, 2017
Record last verified: 2017-01