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While Amgen called the research results encouraging, they are from a Phase II trial, the middle stage of testing.
Biweekly scheduling was studied in this phase II trial.
Thus, this phase II trial suggested that CAPOX therapy has no effect on intrahepatic cholangiocarcinoma.
Methods: The ExSTRESS study (NCT01969149) was a one-center randomized phase II trial.
A Phase II trial with the PARI system is ongoing (NCT01969799).
These results were confirmed in a prospective multicentric phase II trial.
This compound is currently in a phase II trial (ClinicalTrials.gov Identifier: NCT01667536).
Both of the patients described in this report were enrolled in this phase II trial.
The company also plans a phase II trial to study the effect of higher dosages.
Between August 1999 and February 2002, 41 patients entered this multicenter phase II trial.
The regulatory agency recommended a Phase II trial for safety before conducting the efficacy trial.
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