Pancreatic cancer
Conditions
Interventions
- Investigational product (DFP-17729) or control (placebo): Oral administration, 24 tablets per day, divided into four doses, administered daily.
- Concomitant medication (S-1): To be administered at
Sponsors
Iizuka Kenzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed diagnosis of invasive ductal adenocarcinoma of the pancreas. - Unresectable or unresected Stage III/IV disease, or postoperative recurrence. - Presence of at least one measurable or non-measurable lesion according to RECIST version 1.1 within 4 weeks prior to enrollment. - Patients who have received two or more prior regimens of standard systemic therapy, including both gemcitabine-based and fluoropyrimidine-based regimens, and meet all of the following criteria: 1) Refractory or intolerant to both gemcitabine-based and fluoropyrimidine-based regimens. 2) Not refractory or intolerant to the most recent regimen that included S-1. 3) At least 2 weeks have elapsed between the last dose of the most recent prior therapy and the date of enrollment. - Determined by the principal investigator or subinvestigator to be appropriate candidates for treatment with S-1. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Exclusion criteria
Exclusion criteria: - Patients with suspected brain metastases based on clinical findings or a history of brain metastases. - Patients with uncontrolled hypertension. - Patients with active double (synchronous) malignancies. - Patients with moderate or greater ascites based on assessments within 4 weeks prior to enrollment. - Patients with a body mass index (BMI) of less than 18 kg/m^2 based on measurements within 2 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival after PD, Duration of investigational treatment after PD, PFS, DCR, ORR, Tumor shrinkage rate, Tumor marker reduction rate, type and severity of adverse events and side effects (CTCAE ver. 5.0) | — |
Contacts
Public ContactKenzo Iizuka
Delta-Fly Pharma, Inc.
Outcome results
None listed