The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.
Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.
Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.
Participant Incidence of Adverse Events
The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.
Time frame: From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.
Number of Participants With an Objective Tumor Response
The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR.
Time frame: From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.
Tmax
Time after dosing when maximum plasma concentration was observed for AMG 706
Time frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.
Cmax
The maximum observed plasma concentration after AMG 706 dosing
Time frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.
AUC0-24
Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method.
Time frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.
AUC0-inf
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Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.
Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort.
Time frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.