Ser det er kommet endel info om fase 2 på clinical trials (nytt for meg):
"Main objective of the trial :
Extended Part of Phase I
• To determine the tolerability and safety profile of a two-administration
schedule of Amphinex-induced PCI of gemcitabine followed by systemic
gemcitabine/cisplatin chemotherapy in patients with advanced
inoperable cholangiocarcinoma
Phase II
• To make a preliminary assessment of the efficacy of Amphinex-induced
PCI of gemcitabine followed by systemic gemcitabine/cisplatin
chemotherapy in patients with advanced inoperable cholangiocarcinoma
Secondary objectives of the trial:
Extended Part of Phase I
• To characterise the pharmacokinetic profiles of Amphinex and
gemcitabine
• To make a preliminary assessment of the efficacy of a twoadministration
schedule of Amphinex-induced PCI of gemcitabine
followed by systemic gemcitabine/cisplatin chemotherapy in patients
with advanced inoperable cholangiocarcinoma
Phase II
• To characterise the pharmacokinetic profile of Amphinex
• To further assess the safety and efficacy profile of Amphinex-induced
PCI of gemcitabine followed by the systemic gemcitabine/cisplatin
combination
Primary end point(s):
Extended Part of Phase I (Safety)
• Schedule-limiting toxicities and the safety profile (adverse events,
laboratory assessments and physical findings) of a two-administration
schedule of Amphinex-induced PCI of gemcitabine followed by systemic
gemcitabine/cisplatin chemotherapy
Phase II (Efficacy)
• Progression-free survival, defined as the time from randomisation to
documented disease progression (according to Response Evaluation
Criteria in Solid Tumours [RECIST] 1.1 criteria) or death from any cause.
Secondary end point(s):
Extended Part of Phase I
• Pharmacokinetic profile of Amphinex and gemcitabine in plasma
• Progression-free survival, defined as the time from registration to
documented disease progression (according to RECIST 1.1 criteria) or death from any cause
• Best overall response at 24 weeks
Phase II
• Overall response rate, calculated as the proportion of patients with a
best overall response of confirmed complete response or partial
response
• Disease control rate, defined as the proportion of patients with best
overall response of confirmed complete response, partial response or
stable disease
• Overall survival, calculated as the time from randomisation to the date
of death from any cause
• Best overall response
• Pharmacokinetic profile of Amphinex in bile
• Safety profile (adverse events, laboratory assessments and physical
findings) of the Amphinex-induced PCI of gemcitabine followed by the
gemcitabine/cisplatin combination, or the gemcitabine/cisplatin
combination alone
Planned number of subjects to be included
F.4.1 In the member state 39
F.4.2 For a multinational trial
F.4.2.1 In the EEA 68
F.4.2.2 In the whole clinical trial 68"
member state er Tyskland
Det burde vel gi 40 pasienter i PF studien (68-16-12)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-002888-10/DE/#N