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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02178956




Registration number
NCT02178956
Ethics application status
Date submitted
27/06/2014
Date registered
1/07/2014
Date last updated
1/10/2019

Titles & IDs
Public title
A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
Scientific title
A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma
Secondary ID [1] 0 0
2014-000774-18
Secondary ID [2] 0 0
BBI608-336
Universal Trial Number (UTN)
Trial acronym
BRIGHTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastroesophageal Junction Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BBI608
Treatment: Drugs - Paclitaxel
Other interventions - Placebo

Experimental: BBI608 plus Paclitaxel -

Placebo Comparator: Placebo plus Paclitaxel -


Treatment: Drugs: BBI608
BBI608 480 mg orally two times daily (960 mg total daily dose)

Treatment: Drugs: Paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle

Other interventions: Placebo
Orally two times daily

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - The primary objective of this study is to assess the effect of orally administered BBI608 plus weekly paclitaxel, in comparison to placebo plus weekly paclitaxel on the Overall Survival of patients with advanced histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma who failed treatment with one platinum/fluoropyrimidine containing regimen for unresectable or metastatic disease.
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Progression Free Survival - Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Objective Response Rate - Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1.
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Disease Control Rate - Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Number of Patients with Adverse Events - All patients who have received at least one dose of BBI608/Placebo will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.
Timepoint [4] 0 0
36 months

Eligibility
Key inclusion criteria
- Cytologically or histologically confirmed advanced gastric or GEJ adenocarcinoma that
is metastatic or locally advanced and unresectable.

- Failed treatment with one regimen containing at least a platinum/fluoropyrimidine
doublet for unresectable or metastatic disease.Treatment failure is defined as
progression of disease (clinical or radiologic) during first line treatment for
unresectable or metastatic disease or = 6 months after last dose of first line
treatment.

- Paclitaxel therapy is appropriate for the patient and is recommended by the
Investigator.

- Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as
necessary to document all sites of disease done within 21 days prior to randomization.
Patients with either measurable disease OR non-measurable evaluable disease will be
eligible.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

?= 18 years of age.

- For male or female patient of child producing potential: Must agree to use
contraception or take measures to avoid pregnancy during the study and for 6 months
after the final dose of Paclitaxel or for 30 days for female patients and for 90 days
for male patients, of the final BBI608/Placebo dose if Paclitaxel was not
administered.

- Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy
test within 5 days prior to randomization.

- Alanine transaminase (ALT) = 3 × institutional upper limit of normal (ULN) [= 5 × ULN
in presence of liver metastases] within 14 days prior to randomization.

- Hemoglobin (Hgb) = 9.0 g/dL within 14 days prior to randomization. Must not have
required transfusion within 1 week of baseline Hgb assessment.

- Total bilirubin = 1.5 × institutional ULN [= 2.0 x ULN in presence of liver
metastases] within 14 days prior to randomization.

- Creatinine = 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min (as
calculated by the Cockroft-Gault equation) within 14 days prior to randomization.

- Absolute neutrophil count = 1.5 x 10^9/L within 14 days prior to randomization.

- Platelet count = 100 x 10^9/L within 14 days prior to randomization. Must not have
required transfusion within 1 week of baseline platelet assessment.

- Other baseline laboratory evaluations must be done within 14 days prior to
randomization.

- Patient must consent to provision of a representative formalin fixed paraffin block of
tumor tissue, if available, in order that the specific correlative marker assays may
be conducted.

- Patient must consent to provision of a sample of blood in order that the specific
correlative marker assays may be conducted.

- Patients must be accessible for treatment and follow up.

- Protocol treatment is to begin within 2 working days of patient randomization.

- The patient is not receiving therapy in a concurrent clinical study and the patient
agrees not to participate in other interventional clinical studies during their
participation in this trial while on study treatment. Patients participating in
surveys or observational studies are eligible to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Anti-cancer chemotherapy or biologic therapy if administered prior to the first
planned dose of BBI608/placebo within period of time equivalent to the usual cycle
length of the regimen. An exception is made for oral fluoropyrimidines (e.g.
capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior
to the first planned dose of BBI608/placebo.Radiotherapy, immunotherapy, or
investigational agents within four weeks of first planned dose of BBI608/placebo, with
the exception of a single dose of radiation up to 8 Gray (equal to 800 RAD) with
palliative intent for pain control up to 14 days before randomization.

- Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within
6 months of completion of taxane therapy; or any taxanes in the metastatic setting.

- More than one prior chemotherapy regimen administered in the metastatic setting.

- Major surgery within 4 weeks prior to randomization.

- Any known symptomatic brain metastases requiring steroids.

- Women who are pregnant or breastfeeding.

- Gastrointestinal disorder(s) which, in the opinion of the Qualified/Principal
Investigator, would significantly impede the absorption of an oral agent.

- Unable or unwilling to swallow BBI608/placebo capsules daily.

- Uncontrolled intercurrent illness.

- Peripheral neuropathy = CTCAE Grade 2 at baseline.

- History of other malignancies except: adequately treated non-melanoma skin cancer,
curatively treated in-situ cancer of the cervix, or other solid tumors curatively
treated with no evidence of disease for = 3 years.

- Prior treatment with BBI608.

- Any active disease condition which would render the protocol treatment dangerous or
impair the ability of the patient to receive protocol therapy.

- Any condition (e.g. psychological, geographical, etc.) that does not permit compliance
with the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe - Bankstown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
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St Vincent's Hospital - Darlinghurst
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Central coast area health (public) - Gosford
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Port Macquaries Base Hospital - Port Macquarie
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Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 0 0
Riverina Cancer Care Centre - Wagga Wagga
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Royal Brisbane & Women's Hospital - Herston
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Sunshine Coast Hospital and Health Service - Nambour
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Gold Coast University Hospital - Southport
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Townsville Hospital - Townsville
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Princess Alexandra Hospital - Woolloongabba
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Flinders Medical Centre - Bedford Park
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Ashford Cancer Centre Research - Kurralta Park
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The Queen Elizabeth Hospital - Woodville
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Bendigo Hospital - Bendigo
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Monash Health - East Bentleigh
Recruitment hospital [18] 0 0
Peninsula & South Eastern Haematology and Oncology Group - East Bentleigh
Recruitment hospital [19] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [20] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [21] 0 0
Ballarat base hospital - Heidelberg
Recruitment hospital [22] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [23] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [24] 0 0
Ballarat Oncology and Haematology Services - Wendouree
Recruitment hospital [25] 0 0
Fiona Stanley Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [8] 0 0
4029 - Herston
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4560 - Nambour
Recruitment postcode(s) [10] 0 0
4215 - Southport
Recruitment postcode(s) [11] 0 0
4814 - Townsville
Recruitment postcode(s) [12] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 0 0
5042 - Bedford Park
Recruitment postcode(s) [14] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [15] 0 0
5011 - Woodville
Recruitment postcode(s) [16] 0 0
3550 - Bendigo
Recruitment postcode(s) [17] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [18] 0 0
3065 - Fitzroy
Recruitment postcode(s) [19] 0 0
3084 - Heidelberg
Recruitment postcode(s) [20] 0 0
3050 - Parkville
Recruitment postcode(s) [21] 0 0
3021 - St Albans
Recruitment postcode(s) [22] 0 0
3355 - Wendouree
Recruitment postcode(s) [23] 0 0
6008 - Subiaco
Recruitment outside Australia
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Kansas
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Louisiana
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Michigan
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Minnesota
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Missouri
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New Hampshire
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Washington
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Wisconsin
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Belgium
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Antwerpen
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Brussels Capital Region
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Belgium
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Hainaut
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Belgium
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Vlaams Brabant
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Belgium
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Brugge (Assebroek)
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Belgium
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Liège
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Bahia
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Brno
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Praha 2
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Praha 8
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Harjumaa
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Tartumaa
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Alpes-Maritimes
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Bouches-du-Rhône
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Vienne
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Clermont-Ferrand
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Rennes
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Saint Etienne
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Bayern
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Esslingen
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Germany
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Hamburg
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Hungary
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Baranya
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Hungary
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Békés
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Hungary
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Gyor-Moson-Sopron
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Hungary
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Hajdú-Bihar
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Hungary
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Jász-Nagykun-Szolnok
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Hungary
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Szabolcs-Szatmár-Bereg
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Hungary
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Budapest
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Hungary
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Kaposvár
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Israel
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HaDarom
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Israel
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HaMerkaz
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Israel
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Tel-Aviv
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Israel
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Yerushalayim
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Israel
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Haifa
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Italy
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Forli
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Italy
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Ravenna
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Italy
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Ancona
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Catania
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Italy
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Cremona
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Italy
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Genova
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Italy
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Milano
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Italy
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Padova
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Italy
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Piacenza
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Italy
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Torino
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Hokkaido
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Hyogo
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Japan
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Nagano
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Gifu
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Lithuania
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Kauno Apskritis
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Lithuania
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Panevežio Apskritis
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Lithuania
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Vilniaus Apskritis
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Lithuania
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Šiauliu Apskritis
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Poland
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Kujawsko-pomorskie
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Poland
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Malopolskie
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Poland
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Mazowieckie
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Podkarpackie
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Pomorskie
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Poland
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Wielkopolskie
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Poland
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Zachodniopomorskie
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Poland
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Lódzkie
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Maramures
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Romania
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Timis
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Romania
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Bucuresti
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Romania
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Iasi
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Romania
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Lasi
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Romania
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Sibiu
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Russian Federation
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Bahkortostan, Respublika
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Russian Federation
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Leningradskaya Oblast'
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Russian Federation
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Moskva
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Russian Federation
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Russian Federation
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Stavropol'skiy Kray
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Russian Federation
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Krasnodar
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Spain
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Barcelona
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Castilla Y León
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Madrid
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Burgos
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Hospitalet de Llobregat
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Spain
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Murcia
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Sevilla
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Valencia
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Spain
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Zaragoza
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United Kingdom
State/province [165] 0 0
Glasgow City
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Surrey
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Belfast
Country [168] 0 0
United Kingdom
State/province [168] 0 0
London
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Manchester
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sumitomo Dainippon Pharma Oncology, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to find out whether it is better to receive a new drug, BBI608,
in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as
second line treatment for gastric and gastroesophageal junction cancer after prior first line
platinum and fluoropyrimidine based chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT02178956
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
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Email 0 0
Contact person for scientific queries

Summary results
Other publications