Protocol title:   A phase III randomised study of BBI608 and best supportive care versus placebo and best supportive care in patients with pre-treated advanced colorectal carcinoma

Study Chairs:  Dr Louise Nott (Royal Hobart Hospital, TAS); and A/Prof Jeremy Shapiro (Cabrini Haematology & Oncology Centre, Malvern VIC)

Associate Oncology Program Manager:   Eric Tsobanis

Contact Email:

Detailed information  available  on the  Australian and New Zealand Clinical Trials Registry — CO.23

Grants Awarded:

This is an international multi-centre, prospective, double-blind, randomized phase III trial of the cancer stem cell inhibitor BBI608 plus best supportive care  versus  matched placebo plus best supportive care (where best supportive care is defined as those measures designed to provide palliation of symptoms and improve quality of life as much as possible) in patients previously treated with combination chemotherapy for advanced (metastatic or locally advanced), unresectable, colorectal carcinoma, now refractory and for whom no further standard anticancer therapy is appropriate or available.

In Australia colorectal cancer (CRC) is the second most common cancer diagnosed and the second highest cause of cancer related death. In the United States, it is the third most commonly diagnosed malignant disease and third most frequent cause of cancer-related death.    Approximately half of all diagnosed CRC patients will develop disseminated advanced disease, which in most cases will be fatal.
Cancer Stem Cells (CSCs) are a sub-population of cancer cells that have self-renewal capability, are highly malignant and are considered to be fundamentally responsible for malignant growth, recurrence, drug-resistance and metastasis. Moreover, CSCs are highly resistant to chemotherapies and current targeted agents. Findings suggest that the development of cancer stem cell inhibitors represents a novel and compelling strategy for the treatment of CRC.
BBI608 is a small molecule that blocks self-renewal of, and induces cell death in, CSCs isolated from CRC and other types of cancer.
NCIC CTG CO.23 will primarily examine the effect of treatment with CSC inhibitor BBI608 on Overall Survival in patients with metastatic CRC who have failed all standard chemotherapy (including a thymidylate synthase inhibitor, an irinotecan-containing regimen, an oxaliplatin containing regimen and, for patients whose tumours are  K-ras  wild type, either of the EGFR inhibitors cetuximab or panitumumab) recommended by their oncologist, and for whom no standard anticancer therapy is available.

Study Design and Methods:
The CO.23 trial is a multidisciplinary collaboration between the AGITG, NHMRC Clinical Trial Centre, NCIC-CTG and Boston Biomedical Inc.
A total of 650 patients will be randomized according to a 1:1 ratio using a permuted block randomization procedure to receive one of the following treatments:
– BBI608 plus best supportive care
– Placebo plus best supportive care
Best supportive care is defined as those measures designed to provide palliation of symptoms and improve quality of life as much as possible.

To view the study schema click here.

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