Patients with unresectable/recurrent/progressive pancreatic cancer
Conditions
Interventions
Administration period 28 days or more
DFP-17729
Sponsors
Delta-Fly Pharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with 1)Invasive pancreatic ductal carcinoma 2)Stage 3 or 4 3) Have evaluable lesions 4) Standard regimen over 1 regimen 5) Patients with bone marrow or liver or renal function 6)PS 0 or 1 7) Patients expected to survive for 3 months or more 8) Age umder 20 9) Capable of treatment with oral medicine 10)IC
Exclusion criteria
Exclusion criteria: Patient without 1) Obvious infection 2) Severe heart diseases 3) Severe complicatios 4) Brain metasitases 5) Severe digestive diseases 6) Severe thromboembolisms 7) Severe diarrhea 8) Severe psychosis 9) Double cancer 10) Pregnant woman/ Breastfeeding 11) Continuous systemic administration of steroids 12) Effects of pretreatment 13) Blood transfusion and blood component preparation 14) Patients judged to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 DLT Phase 2 OS | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 Safety assessment Adverse event, Side effects Pharmacokinetic evaluation Effectiveness evaluation ORR,DCR,CEA,CA19-9 Phase 2 Effectiveness evaluation PFS,ORR,DCR, CEA,CA19-9 Safety assessment Adverse event, Side effects | — |
Countries
Japan
Contacts
Public ContactKenzo Iizuka
Delta-Fly Pharma, Inc. R and D
Outcome results
None listed