A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
Conditions
Gastric Cancer - Gastroesophageal Junction Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: BBI608 Type: Drug
Name: Paclitaxel Type: Drug
Name: Placebo Type: Other
Overall Status
Recruiting
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.
Detailed Description
The goal of this study is to determine if paclitaxel given together with BBI608 as second line therapy will prolong overall survival compared to paclitaxel alone.

Approximately 680 patients will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma.

Patients must have failed first line therapy with any platinum/fluoropyrimidine doublet.

BBI608/placebo will be administered daily, paclitaxel will be administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 ≤ 4 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 28 days after the last Protocol treatment dose.

- 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 Cockcroft-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, listed in Section 6.0, 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.

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.
Locations
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
Status: Recruiting
Colorado Cancer Research Program
Denver, Colorado, United States
Status: Recruiting
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Status: Recruiting
Siouxland Regional Cancer Center
Souix City, Iowa, United States
Status: Recruiting
Cancer Center of Kansas
Wichita, Kansas, United States
Status: Recruiting
Ochsner NCI CORP
New Orleans, Louisiana, United States
Status: Recruiting
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Status: Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Status: Recruiting
Metro-Minnesota NCI CORP
St. Louis Park, Minnesota, United States
Status: Recruiting
Heartland NCORP
St. Louis, Missouri, United States
Status: Recruiting
New Hampshire Oncology Hematology - Concord
Concord, New Hampshire, United States
Status: Recruiting
New Hampshire Oncology Hematology - Laconia
Laconia, New Hampshire, United States
Status: Recruiting
Weill Medical College of Cornell University
New York, New York, United States
Status: Recruiting
State University of New York Upstate Medical University
Syracuse, New York, United States
Status: Recruiting
The Ohio State University
Columbus, Ohio, United States
Status: Recruiting
Geisinger Medical Center
Danville, Pennsylvania, United States
Status: Recruiting
Virginia Mason Medical Center
Seattle, Washington, United States
Status: Recruiting
Saint Vincent Hospital CCOP
Green Bay, Wisconsin, United States
Status: Recruiting
St. Mary's Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Gundersen Lutheran Medical Center
LaCrosse, Wisconsin, United States
Status: Recruiting
Marshfield CCOP
Marshfield, Wisconsin, United States
Status: Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Status: Recruiting
Sunshine Coast Hospital and Health Service
Nambour, Queensland, Australia
Status: Recruiting
Gold Coast University Hospital
Southport, Queensland, Australia
Status: Recruiting
Townsville Hospital
Townsville, Queensland, Australia
Status: Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Status: Recruiting
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Status: Recruiting
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Status: Recruiting
Monash Health
East Bentleigh, Victoria, Australia
Status: Recruiting
Austin Hospital
Heidelberg, Victoria, Australia
Status: Recruiting
Royal Melbourne Hospital
Parkville, Victoria, Australia
Status: Recruiting
Sunshine Hospital
St Albans, Victoria, Australia
Status: Recruiting
Imelda Ziekenhuis
Bonheiden, Antwerpen, Belgium
Status: Recruiting
UZ Antwerpen
Edegem, Antwerpen, Belgium
Status: Recruiting
Cliniques Universitaires Saint-Luc
Bruxelles, Brussels Capital Region, Belgium
Status: Recruiting
Institut Jules Bordet
Bruxelles, Brussels Capital Region, Belgium
Status: Recruiting
CHU Ambroise Paré
Mons, Hainaut, Belgium
Status: Recruiting
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, Belgium
Status: Recruiting
AZ Sint-Lucas - Campus Sint-Lucas
Brugge (Assebroek), Belgium
Status: Recruiting
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
Status: Recruiting
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
Status: Recruiting
Centre Paul Papin
St Herblain Cedex, Loire-Atlantique, France
Status: Not yet recruiting
Centre Rene Gauducheau
St Herblain Cedex, Loire-Atlantique, France
Status: Not yet recruiting
Hospital of Poitiers
Poitiers, Vienne, France
Status: Recruiting
Hôpital Morvan - CHRU de Brest
Brest Cedex, France
Status: Recruiting
CHU Estaing
Clermont-Ferrand, France
Status: Recruiting
CHU - Hôpital De La Timone
Marseille, France
Status: Recruiting
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt/Main, Hessen, Germany
Status: Not yet recruiting
Ev. Krankenhaus Bielefeld
Bielefeld, Nordrhein-Westfalen, Germany
Status: Recruiting
Kliniken Essen-Mitte Evang. Huyssens-Stiftung
Essen, Nordrhein-Westfalen, Germany
Status: Recruiting
Johannes Gutenberg-Universitaet
Maintz, Rheinland-Pfalz, Germany
Status: Recruiting
Universitätsklinik Carl-Gustav-Carus Dresden
Dresden, Sachsen, Germany
Status: Not yet recruiting
Universitätsklinikum Leipzig
Leipzig, Sachsen, Germany
Status: Recruiting
OncoResearch Lerchenfeld GmbH
Hamburg, Germany
Status: Recruiting
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary
Status: Recruiting
Békés Megyei Pándy Kálmán Kórház
Gyula, Békés, Hungary
Status: Not yet recruiting
Petz Aladár Megyei Oktató Kórház
Gyor, Gyor-Moson-Sopron, Hungary
Status: Recruiting
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary
Status: Recruiting
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté
Szolnok, Jász-Nagykun-Szolnok, Hungary
Status: Recruiting
Josa Andras Oktato Korhaza
Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary
Status: Recruiting
Egyesített Szent István és Szent László Kórház-Rendelőintéze
Budapest, Hungary
Status: Recruiting
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary
Status: Recruiting
Soroka Medical Center [Oncology]
Beer Sheva, HaDarom, Israel
Status: Recruiting
The E. Wolfson Medical Center [Oncology]
Holon, HaMerkaz, Israel
Status: Recruiting
Meir Medical Center
Kfar Saba, HaMerkaz, Israel
Status: Recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikva, HaMerkaz, Israel
Status: Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel-Aviv, Israel
Status: Recruiting
Hadassah Medical Organisation
Jerusalem, Yerushalayim, Israel
Status: Recruiting
Rambam Health Care Campus
Haifa, Israel
Status: Recruiting
Irccs Irst
Meldola, Forli, Italy
Status: Recruiting
AUSL della Romagna, Osp. degli Infermi
Faenza, Ravenna, Italy
Status: Recruiting
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna, Italy
Status: Recruiting
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania, Italy
Status: Recruiting
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, Italy
Status: Recruiting
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
Genova, Italy
Status: Recruiting
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milano, Italy
Status: Recruiting
Iov-Irccs
Padova, Italy
Status: Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan
Status: Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Status: Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Status: Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Status: Recruiting
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan
Status: Recruiting
Saku Central Hospital Advanced Care Center
Saku, Nagano, Japan
Status: Recruiting
Osaka University Hospital
Suita, Osaka, Japan
Status: Recruiting
Saitama Cancer Center
Kita-Adachi, Saitama, Japan
Status: Recruiting
Shizuoka Cancer Center
Sunto, Shizuoka, Japan
Status: Recruiting
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Status: Recruiting
National Cancer Center Hospital
Chuo, Tokyo, Japan
Status: Recruiting
Kyorin University Hospial
Mitaka, Tokyo, Japan
Status: Recruiting
Chiba Cancer Center
Chiba, Japan
Status: Recruiting
Gifu University Hospital
Gifu, Japan
Status: Recruiting
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan
Status: Recruiting
Seoul National University Bundang Hospital
SeongNam, Gyeonggido, Korea, Republic of
Status: Recruiting
Asan medical Center
Seoul, Seoul Teugbyeolsi, Korea, Republic of
Status: Recruiting
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, Korea, Republic of
Status: Not yet recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, Korea, Republic of
Status: Recruiting
Hospital of Lithuanian University of Health Sciences
Kaunas, Kauno Apskritis, Lithuania
Status: Recruiting
Hospital of Lithuanian University of Health sciences
Kaunas, Kauno Apskritis, Lithuania
Status: Recruiting
Respublikine Panevezio ligonine
Panevezys, Panevežio Apskritis, Lithuania
Status: Not yet recruiting
National Cancer Institute
Vilnius, Vilniaus Apskritis, Lithuania
Status: Recruiting
Klaipeda University Hospital
Klaipeda, Lithuania
Status: Recruiting
Vilniaus Universiteto ligonines Santariskiu Klinikos
Vilnius, Lithuania
Status: Recruiting
Siauliai County Hospital
Soauliai, Šiauliu Apskritis, Lithuania
Status: Not yet recruiting
Centrum Onkologii im. F.Lukaszczyka
Bydgoszcz, Kujawsko-pomorskie, Poland
Status: Recruiting
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Warszawa, Mazowieckie, Poland
Status: Recruiting
Magodent sp. z o.o. Szpital Onkologiczny
Warszawa, Mazowieckie, Poland
Status: Recruiting
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
Brzozow, Podkarpackie, Poland
Status: Recruiting
Wojewodzkie Centrum Onkologii w Gdansku
Gdansk, Pomorskie, Poland
Status: Recruiting
NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne
Poznan, Wielkopolskie, Poland
Status: Recruiting
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
Lodz, Łódzkie, Poland
Status: Recruiting
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, Romania
Status: Recruiting
Oncolab
Craiova, Dolj, Romania
Status: Recruiting
Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare
Baia-Mare, Maramures, Romania
Status: Not yet recruiting
Oncomed
Timisoara, Timis, Romania
Status: Recruiting
Spitalul Clinic Municipal de Urgenta Timisoara
Timisoara, Timis, Romania
Status: Not yet recruiting
Med Life
Bucuresti, Romania
Status: Recruiting
Spitalul Clinic CF 2
Bucuresti, Romania
Status: Recruiting
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Romania
Status: Recruiting
Republican Clinical Oncology Dispensary
Ufa, Bahkortostan, Respublika, Russian Federation
Status: Recruiting
Military Medical Academy n.a. S.M. Kirov
Saint Petersburg, Leningradskaya oblast', Russian Federation
Status: Recruiting
City Clinical Hospital #40
Moscow, Moskva, Russian Federation
Status: Recruiting
Russian Oncological Research Center n.a. N.N. Blokhin RAMS
Moscow, Moskva, Russian Federation
Status: Recruiting
GUZ Perm Regional Oncology Dispensary
Perm, Permskiy kray, Russian Federation
Status: Recruiting
First Pavlov State Medical University of Saint-Petersburg
Saint Petersburg, Sankt-Peterburg, Russian Federation
Status: Recruiting
GBUZ Saint Petersburg clinical scientific and practical cent
Saint Petersburg, Sankt-Peterburg, Russian Federation
Status: Recruiting
Northwestern State Medical University n.a. Mechnikov
Saint Petersburg, Sankt-Peterburg, Russian Federation
Status: Recruiting
SPb State Budget Institution Oncology Dispansery
Saint Petersburg, Sankt-Petersburg, Russian Federation
Status: Recruiting
GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary
Pyatigorsk, Stavropol'skiy kray, Russian Federation
Status: Recruiting
Guz Clinical Oncology Dispensary #1
Krasnodar, Russian Federation
Status: Recruiting
Institut Català d'Oncologia-Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Status: Recruiting
C.A.AV-H.Ntra.Sra.de Sonsoles
Avila, Castilla y León, Spain
Status: Recruiting
H.U.P Hierro-Majadahonda
Majadahonda, Madrid, Spain
Status: Recruiting
Hospital Universitario Vall d'Hebrón
Barcelona, Spain
Status: Recruiting
H.U. de Burgos
Burgos, Spain
Status: Recruiting
H.U. R. y Cajal
Madrid, Spain
Status: Recruiting
H.U.V. del Rocío
Sevilla, Spain
Status: Recruiting
H.U. Miguel Servet
Zaragoza, Spain
Status: Recruiting
Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, United Kingdom
Status: Recruiting
The Beatson West Of Scotland Cancer Centre
Glasgow, Glasgow City, United Kingdom
Status: Not yet recruiting
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Status: Recruiting
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Status: Recruiting
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Status: Recruiting
Start Date
August 2014
Sponsors
Boston Biomedical, Inc
Source
Boston Biomedical, Inc
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page