A Phase 1/1b Study of Paclitaxel in Combination with BOS172722
Research type
Research Study
Full title
A Phase 1/1b Study of Paclitaxel in Combination with BOS172722, a Monopolar Spindle 1 Kinase Inhibitor, in Patients with Advanced Nonhaematologic Malignancies
IRAS ID
229728
Contact name
Udai Banerji
Contact email
Sponsor organisation
Boston Pharmaceuticals Inc.,
Eudract number
2017-001749-29
Duration of Study in the UK
0 years, 18 months, 0 days
Research summary
This study is a phase 1/1b study. The purpose of the study is to look at the safety of the experimental study medication BOS172722 and see what effects it has on patient and patient’s cancer. Laboratory tests of BOS172722 have shown that it can kill cancer cells by stopping them reproducing.
The aims of this study are to:
study the side effects of BOS172722, understand how the body handles BOS1727722,
study what BOS172722 does to the body and its effect on the cancer, find the dose of BOS172722 that may be used in future studies.
The study is divided into 2 parts Dose escalation (Part A) and Dose expansion (Part B).
Approximately 6 UK centres are plan to enrol 48 patients in Part A (dose escalation) of the study if 6 patients are assigned to each of up to 8 dose levels. However, additional patients and dose levels may be added if exploration of intermediate doses of BOS172722 is warranted. Approximately 20 additional patients with triple-negative breast cancer (TNBC) will be enrolled in Part B (expansion) of the study.
Approximately 68 patients in total (48 in Part A and 20 in Part B) will be treated in up to 6 hospitals in the United Kingdom as part of this study.
The total duration of this study is anticipated to be approximately 18 months, including enrolment, treatment, and follow-up.REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/1347
Date of REC Opinion
25 Sep 2017
REC opinion
Favourable Opinion