Pancreatic cancer
Conditions
Interventions
Product Name: S-1
Product Code: S-1
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tegafur
CAS Number: 17902-23-7
Current Sponsor code: FT
Other descriptive name: Futraful, FT-207
Concentration un
Sponsors
Taiho Pharma USA, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has provided written informed consent. 2. Has histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery. 3. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, lesions that can be accurately measured in at least one dimension with the longest diameter = 20 mm using conventional techniques or = 10 mm using spiral computed tomography [CT] scan). 4. Is able to take medications orally. 5. Is 18 years of age or older. 6. Has a Karnofsky Performance Status (KPS) = 70% 7. Has a life expectancy of =12 weeks. 8. Has adequate organ function as defined by the following criteria: a. Transaminases AST (SGOT) and ALT (SGPT) = 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be = 5 times ULN. b. Total serum bilirubin = 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be = 5 times ULN). c. Absolute granulocyte count = 1,500/mm3 (ie, = 1.5 x 10 9/L by International Units [IU]). d. Platelet count = 100,000/mm3 (IU: =100 x 10 9/L). e. Hemoglobin value = 9.0 g/dL. f. Calculated creatinine clearance = 60 mL/min (based on serum creatinine) (Cockcroft-Gault formula). 9. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has had treatment with any of the following within the specified time frame prior to study drug administration: a. Any prior anticancer chemotherapy. b. Radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease). c. Any radiotherapy within the previous 3 weeks. d. Any investigational agent received either concurrently or within the last 30 days. e. Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this tudy. 2. Major surgery within the previous 3 weeks. 3. Symptomatic brain metastasis not controlled by corticosteroids. 4. Leptomeningeal metastasis. 5. Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer. 6. Uncontrolled ascites requiring drainage at least twice a week. 7. Other serious illness or medical condition(s) including, but not limited to, the following: a. Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class III or IV, see Appendix F), angina pectoris, arrhythmias, or hypertension. b. Active infection. c. Known (at time of entry) gastrointestinal disorder, including malabsorption, chronic nausea, vomiting, or diarrhea, present to the extent that it might interfere with oral intake and absorption of study medication. d. Poorly controlled diabetes mellitus. e. Psychiatric disorder that may interfere with consent and/or protocol compliance. f. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. g. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study. 8. Is receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: a. Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity). b. Allopurinol (may diminish S-1 activity). c. Phenytoin (S-1 may enhance phenytoin activity). d. Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity and flucytosine activity). 9. Is a pregnant or lactating female. 10. Has known hypersensitivity to 5-FU. 11. Is a patient with reproductive potential who refuses to use an adequate means of contraception (including male patients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antitumor acitivity, as assessed by objective tumor response (overall response rate [ORR] of single agent S-1 in chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer.;Secondary Objective: - To evaluate the disease control rate (DCR), duration of response (DR), time to tumor progression (TTP), and survival rate. -To evaluate the safety profile of S-1 -To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters (optional). -To investigate the effect of S-1 on Karnofsky Performance Status (KPS) and pain assessments, including pain intensity and analgesic consumption;Primary end point(s): Overall Response Rate (ORR). The primary statistical assessment of ORR at the end of the study will be based on an independent review of the images by a core imaging laboratory based on the RECIST criteria. | — |
Countries
Germany
Outcome results
None listed