Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02178956
Ethics application status
Date submitted
27/06/2014
Date registered
1/07/2014
Date last updated
15/11/2023

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
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Objective Response Rate
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Disease Control Rate
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Number of Patients With Adverse Events
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
Sex
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
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2017
Sample size
Target
Accrual to date
Final
714
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
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Central coast area health (public) - Gosford
Recruitment hospital [5] 0 0
Port Macquaries Base Hospital - Port Macquarie
Recruitment hospital [6] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [8] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [9] 0 0
Sunshine Coast Hospital and Health Service - Nambour
Recruitment hospital [10] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [11] 0 0
Townsville Hospital - Townsville
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [13] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [14] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [15] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [16] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [17] 0 0
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
Recruitment postcode(s) [9] 0 0
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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United States of America
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Arizona
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Colorado
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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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United States of America
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Washington
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United States of America
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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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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Brazil
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Bahia
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Ceará
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Paraná
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Rio Grande Do Sul
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Santa Catarina
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Brno
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Praha 2
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Czechia
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Praha 8
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Harjumaa
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Estonia
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Tartumaa
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Alpes-Maritimes
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Vendée
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Vienne
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Brest Cedex
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Clermont-Ferrand
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Marseille
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France
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Rennes
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Saint Etienne
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Toulouse cedex
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Villejuif
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Germany
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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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Catania
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Italy
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Cremona
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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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Japan
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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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Malopolskie
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Mazowieckie
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Podkarpackie
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Pomorskie
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Wielkopolskie
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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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Permskiy Kray
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Sankt-Petersburg
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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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Andalucía
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Spain
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Barcelona
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Spain
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Castilla Y León
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Spain
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Madrid
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Spain
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Burgos
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Spain
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Hospitalet de Llobregat
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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United Kingdom
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Aberdeen City
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United Kingdom
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Glasgow City
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United Kingdom
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Surrey
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United Kingdom
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Belfast
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London
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United Kingdom
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Manchester
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sumitomo Pharma America, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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Results are available at https://clinicaltrials.gov/study/NCT02178956