ABC-04 a Phase 1B Study of Cisplatin, Gemcitabine and Selumetinib in Patients With Advanced Biliary Tract Cancer
This trial aims to evaluate the safety and tolerability of selumetinib in combination with
CisGem and to establish the recommended dose to take into phase II studies. Pharmacokinetic
and pharmacodynamic endpoints will be assessed and preliminary efficacy data will also be
collected.
Patients with Advanced Biliary tract Cancer will receive CisGem regimen and selumetinib. A
dose de-escalation scheme will be employed to determine the recommended phase II dose of
selumetinib.
Patients will be recruited in cohorts of three and assessed for dose limiting toxicity (DLT)
during the first cycle of treatment. Depending on the number of DLTs observed, the cohort
may be expanded, the next cohort may be enrolled at a lower dose or the dose may be declared
the recommended dose. Patients will receive up to eight cycles of CisGem and may continue to
receive selumetinib until progression of disease.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To investigate the safety and tolerability of the combination of cisplatin, gemcitabine and selumetinib, and to establish the recommended phase II dose of selumetinib when given in this combination.
To investigate the safety and tolerability of the combination of cisplatin, gemcitabine (CisGem) and selumetinib and to establish the recommended phase II dose of selumetinib when given in this combination. The recommended dose of selumetinib to use in combination with CisGem in future studies will be the dose at which less than 33% of patients experience a DLT. The recommended dose will not be higher than 75mg/m*2
from baseline to 28 days post last patient last treatment
Yes
John Bridgewater, MD
Principal Investigator
UCL
United Kingdom: Medicines and Healthcare Products Regulatory Agency
ABC-04
NCT01242605
February 2012
August 2013
Name | Location |
---|