This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
100 mg lyophilisate in vial received 400 mg every 4 weeks
120 mg once daily first 21 days of each 28-day cycle (=4 weeks)
Novartis Investigative Site
St Leonards, New South Wales, Australia
Novartis Investigative Site
Murdoch, Western Australia, Australia
Novartis Investigative Site
Montreal, Quebec, Canada
Incidence of Dose-limiting toxicity (DLT)
A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.
Time frame: 8 Weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.
Time frame: Up to 150 days after last administration of PDR001
Severity of AEs and SAEs
Severity including dose interruptions and reductions.
Time frame: Up to 150 days after last administration of PDR001
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Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
...and 1 more locations