SHS_492301 GOLP CBBI 15200

A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of BBI608 plus Weekly Paclitaxel vs Placebo plus Weeky 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.

Select 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.
•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.
•Certain labs within specific limits (see protocol).
•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.
•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.

Select 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. Some exceptions are allowed (see protocol).
•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.
•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.
Phase III
Philip Gold, M.D.
Boston Biomedical
Erik Bailey
  • Swedish Medical Center