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A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

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Trial Profile

A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 18 Oct 2023

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At a glance

  • Drugs Napabucasin (Primary) ; Paclitaxel
  • Indications Adenocarcinoma; Advanced breast cancer; Fallopian tube cancer; Gastric cancer; Head and neck cancer; Male breast cancer; Malignant melanoma; Malignant thymoma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Peritoneal cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions
  • Sponsors Boston Biomedical; Sumitomo Dainippon Pharma Oncology; Sumitomo Pharma America

Most Recent Events

  • 31 Jan 2023 Number of treatment arms have been increased from 1 to 5 by the addition of dose levels of 200 mg, 240 mg, 400 mg, 480 mg and 500 mg. Timelines for primary end points have been changed from 6 months to 4 months for AEs and SAEs and 28 days for DLT. Study design is updated from single group assignment to sequential.
  • 08 Jul 2021 Status changed from active, no longer recruiting to completed.
  • 27 Apr 2021 Planned End Date changed from 1 Dec 2021 to 1 Jun 2021.

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