Back to resultsEfficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer (SHINE)
Primary Purpose
Gastro-oesophageal Junction Cancer, Gastric Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD4547
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-oesophageal Junction Cancer focused on measuring gastro-oesophageal junction cancer, gastric cancer, lower third oesophageal cancer, polysomy, amplification, FGFR
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
- Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AZD4547
Paclitaxel
Arm Description
AZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule
Paclitaxel - 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)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)
Objective Response Rate
ORR=Percentage of patients with at least one visit response of CR (complete response) or PR (partial response) that is confirmed at least 4 weeks later; CR:disappearance of target lesions and no new lesions; PR is at least 30% decrease in sum of diameters of lesions taking as a reference the smallest sum since treatment started.
Percentage Change From Baseline at Week 8 in Target Lesion Size
A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.
Percentage of Patients Without Progressive Disease at 8 Weeks
PD = A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diamters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01457846
Brief Title
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
Acronym
SHINE
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
Detailed Description
A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-oesophageal Junction Cancer, Gastric Cancer
Keywords
gastro-oesophageal junction cancer, gastric cancer, lower third oesophageal cancer, polysomy, amplification, FGFR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
960 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD4547
Arm Type
Experimental
Arm Description
AZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule
Arm Title
Paclitaxel
Arm Type
Active Comparator
Arm Description
Paclitaxel - 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)
Intervention Type
Drug
Intervention Name(s)
AZD4547
Intervention Description
Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Infusion administered once a week, 3 weeks on and 1 week off
Primary Outcome Measure Information:
Title
Median Progression Free Survival
Description
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).
Time Frame
Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)
Secondary Outcome Measure Information:
Title
Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)
Time Frame
Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)
Title
Objective Response Rate
Description
ORR=Percentage of patients with at least one visit response of CR (complete response) or PR (partial response) that is confirmed at least 4 weeks later; CR:disappearance of target lesions and no new lesions; PR is at least 30% decrease in sum of diameters of lesions taking as a reference the smallest sum since treatment started.
Time Frame
Week 8 (±1 week) and then every 8 weeks (±1 week)
Title
Percentage Change From Baseline at Week 8 in Target Lesion Size
Description
A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.
Time Frame
Baseline, Week 8 (±1 week)
Title
Percentage of Patients Without Progressive Disease at 8 Weeks
Description
PD = A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diamters
Time Frame
Week 8 (±1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Stockman, MD PHD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric Van Cutsem, MD PHD
Organizational Affiliation
University Hospital, Gasthuisberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yung-Jue Bang, MD, PHD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Brussels (Anderlecht)
Country
Belgium
Facility Name
Research Site
City
Brussels (Woluwé-St-Lambert)
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Vratza
Country
Bulgaria
Facility Name
Research Site
City
Fredericton
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Saint Cloud
Country
France
Facility Name
Research Site
City
Villejuif
Country
France
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
Country
Hungary
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Chennai
Country
India
Facility Name
Research Site
City
Hyderabad
Country
India
Facility Name
Research Site
City
Nagpur
Country
India
Facility Name
Research Site
City
Pune
Country
India
Facility Name
Research Site
City
Vellore
Country
India
Facility Name
Research Site
City
Ancona
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Pisa
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Chiba-shi
Country
Japan
Facility Name
Research Site
City
Chuo-ku
Country
Japan
Facility Name
Research Site
City
Koto-ku
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
Country
Japan
Facility Name
Research Site
City
Takatsuki-shi
Country
Japan
Facility Name
Research Site
City
Anyang-si
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
Country
Korea, Republic of
Facility Name
Research Site
City
Hwasun-gun
Country
Korea, Republic of
Facility Name
Research Site
City
Jeonju-si
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
Country
Romania
Facility Name
Research Site
City
A Coruña
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Oviedo
Country
Spain
Facility Name
Research Site
City
Santander
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Keelung
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
Country
Taiwan
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Aberdeen
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Sutton
Country
United Kingdom
Facility Name
Research Site
City
Wolverhampton
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1284&filename=D2610C00004_ProtocolCSP_2Redactions_marked14Dec15_Redacted.pdf
Description
D2610C00004redacted_protocol
Learn more about this trial
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
We'll reach out to this number within 24 hrs