Introduction to Cancer Stem Cell Inhibitor BBI608 (Napabucasin)

• May 9, 2016
• 1 min read

A Phase 3 clinical trial evaluating paclitaxel combined with BBI608 in previously treated gastric cancer patients.

Trial Period: November 2014 – August 2017

Trial Sites: Japan, United States, Australia, Russia, Germany, and other countries

Enrollment Target: 680 patients

Investigational Drug: BBI608 — a targeted molecular agent (cancer stem cell inhibitor)

Trial Overview: This trial targeted previously treated gastric cancer patients (including gastroesophageal junction adenocarcinoma), administering weekly paclitaxel combined with BBI608 or placebo. BBI608 is a low-molecular-weight oral drug employing a novel mechanism against cancer stem cells—cells that possess stem cell-like properties and are believed to be responsible for cancer recurrence and metastasis. While existing anticancer drugs can kill or suppress conventional cancer cells, they are generally ineffective against cancer stem cells. BBI608 acts on both cancer stem cells and regular cancer cells, making it a promising candidate for new therapeutic approaches.

For reference: Dainippon Sumitomo Pharma website: http://www.ds-pharma.co.jp/ir/topic/

Eligibility Criteria:

1. Age 20 or older (note: ClinicalTrials.gov lists age 18 or older)
2. Prior treatment with platinum-based agents (e.g., cisplatin, oxaliplatin) with documented resistance
3. ECOG Performance Status (PS) 0–1

Exclusion Criteria:

1. Patients receiving corticosteroids for other medical conditions with brain metastases
2. Patients who developed resistance to paclitaxel or experienced disease progression while on paclitaxel

(Plus other standard exclusion criteria)

Clinical Trial References:

• ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02178956
• Clinical JP: http://www.clinicaltrials.jp/user/search/directCteDetail.jsp?clinicalTrialId=12203

Japan Clinical Trial Contact:

• Organization: Dainippon Sumitomo Pharma Co., Ltd.
• Department: Corporate Communications Division
• Contact: pr@ds-pharma.co.jp

Immunotherapy | Esophageal Cancer | Gastric Cancer

• Clinical Trial Medications

  • (Lung Cancer) Phase II results for Topotecan and Topotecan + Berzosertib combination.
  • (Lung Cancer) Efficacy of Enhertu in HER2-mutant non-small cell lung cancer (NSCLC).
  • (Lung Cancer) Clinical outcomes of anti-B7-H3 antibody-drug conjugate DS-7300.

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