Unresectable or Recurrent Biliary Tract Cancer
Conditions
Interventions
phase I part
DFP-11207 at a dose of 300-900 mg according to body surface area, until disease progression, intolerance, or patient's refusal
phase II part
DFP-11207 at the recommended dose of phase I
Sponsors
Ueno Makoto
Japan Oncology Network in Hepatobiliary and Pancreas
Eligibility
Inclusion criteria
Inclusion criteria: 1 The pathological diagnosis, which was based on histological or cytological findings, indicates that the main tissue type is adenocarcinoma. 2 Chest CT and abdominal,pelvic CT have diagnosed unresectable and recurrent biliary tract cancer. 3 The subjects are 18 years of age or older at the time of registration.
Exclusion criteria
Exclusion criteria: 1) Subjects with multiple biliary tract cancers 2) Subjects with active multiple cancers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [phase I part] Safety and recommended dose [phase II part] Progression-free survival (Independent central review) | — |
Secondary
| Measure | Time frame |
|---|---|
| phase I part Maximum tolerate dose, dose limiting toxicity, adverse events and serious adverse events, objective response rate, disease control rate phase II part Overall survival, progression-free survival (investigator's review), objective response rate, disease control rate, adverse events, serious adverse events | — |
Contacts
Public ContactSatoshi Kobayashi
Kanagawa Cancer Center
Outcome results
None listed