Boston Biomedical: The BRIGHTER Study
Research type
Research Study
Full title
A Phase 3 Randomised, Double-Blind, Placebo-Controlled 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
IRAS ID
160335
Contact name
Sheetal Dyall
Contact email
Sponsor organisation
Boston Biomedical, Inc
Eudract number
2014-000774-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
100,887, FDA IND Number
Duration of Study in the UK
2 years, 6 months, 16 days
Research summary
Gastric and gastro-esophageal junction (GEJ) cancers are highly lethal malignancies, and have the second highest death rate of all cancers worldwide.
Over 70% of patients diagnosed with gastric and GEJ cancer present with advanced stage disease. Despite advances in the development of targeted therapy for gastric and GEJ cancer, survival rates remain poor and treatment options for advanced disease are limited. Consequently, there is an urgent need to identify novel therapies to improve the outcome of patients with advanced gastric and GEJ cancers.
Cancer stem cells (CSC) are a sub-population of highly malignant cancer cells that have been implicated in tumour initiation, progression, recurrence, metastasis and resistance to conventional chemotherapy. Accumulating evidence indicates that CSC play a significant role in the pathogenesis of gastric cancer, and targeting CSC in gastric and GEJ cancer may lead to improvement in the treatment of this type of cancer.
BBI608 is a CSC inhibitor developed by Boston Biomedical, Inc (BBI). In clinical trials, BBI608 has shown encouraging beneficial effects in patients with advanced disease. In addition, adverse events related to BBI608 were generally mild.
BBI is sponsoring a study to assess the effect of BBI608 in combination with paclitaxel on the overall survival in patients with advanced gastric and GEJ cancer. Patients with advanced gastric and GEJ cancer, who have received treatment previously, but the cancer has now progressed or worsened, will be randomly assigned to one of two treatment arms, as described below. This is a randomized, double-blind, placebo-controlled study, meaning that neither the patient nor the study doctor will know whether the patient is being given the study drug BBI608 or placebo (placebo is defined as a substance that is designed not to have any medical effect).
Treatment Arm 1: BBI608 480mg orally twice daily + Paclitaxel intravenously once weekly for 3 out of every 4 weeks
Treatment Arm 2: Placebo orally twice daily + Paclitaxel intravenously once weekly for 3 out of every 4 weeksThis is a multicentre study which will take place across North and South America, Europe and Asia-Pacific, and will last approximately 2 ½ years. About 680 participants are expected to be recruited.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/2119
Date of REC Opinion
12 Dec 2014
REC opinion
Favourable Opinion