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
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
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.
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 700 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.
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.
Exclusion Criteria:
Oklahoma City, Oklahoma 73104, United States
East Bentleigh, Victoria 3165, Australia
East Bentleigh, Victoria 3165, Australia
Heilongjiang, Heilongjiang 150081, China
Maintz, Rhineland-Palatinate 55101, Germany
Szolnok, Jász-Nagykun-Szolnok 5004, Hungary
Holon, Central District 58100, Israel
Kita-Adachi, Saitama, Japan
Sunto, Shizuoka, Japan
Otwock, Masovian Voivodeship 05-400, Poland
Brzozów, Podkarpackie Voivodeship 36-20, Poland
Lasi, Lasi 700483, Romania
Saint Petersburg, Leningradskaya Oblast' 190121, Russia
Saint Petersburg, Sankt-Peterburg 195067, Russia
Saint Petersburg, Sankt-Peterburg 197022, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Sutton, Surrey SM2 5PT, United Kingdom