metastatic pancreatic cancer MedDRA version: 9.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic MedDRA version: 9.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable
Conditions
Interventions
Trade Name: Helpin RP101 (BVDU)
Product Name: Brivudin (BVDU)
Product Code: RP101
Pharmaceutical Form: Tablet
INN or Proposed INN: BRIVUDINE
CAS Number: 69304478
Current Sponsor code: RP101
Concentrat
Sponsors
SciClone Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects 19 years of age or older 2. Subjects with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas that is unresectable, locally advanced or metastatic 3. ECOG performance status 0 or 1 4. Life expectancy of at least 3 months 5. Documentation of all sites of pancreatic cancer disease withing 28 days prior to treatment start by CT or spiral CT or MRI scan of chest, abdomen, brain (only if clinical suspicion of metastasis), and other scans necessary. Negative scans performed within 35 days of randomization do not need to be repeated 6. Adequate hematological, renal, and hepatic function within 14 days prior to treatment start defined as follows: -Hemoglobin (HGB) = 9.0 gm/dL (prior transfusion and/or support with erythropoietin-based products is acceptable) -Absolute granulocyte count = 1.5 x 109/L (1500 cells/mm3) unsupported for 1 week by growth factors -Platelet count = 100 x 109/L (100,000/mm3) non-platelet transfusion dependent -Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior history of other malignant tumors, except non-melanoma skin cancer or in situ cervical carcinoma curatively excised. Subject may be included if disease-free of cancers other than pancreatic cancer for 5 years 2. Major surgery within 2 weeks prior to treatment start 3. Any prior cytotoxic chemotherapy other than 5-FU (+/- folinic acid) or gemcitabine given concurrently with radiation treatment as a “radiosensitizer”. 5-FU must not have been given within 21 days prior to randomization. 4. Radiation treatment within 4 weeks of treatment start. Prior radiation treatment for management of local disease is allowed, provided that local disease progression or progression by new measurable metastasis outside of the radiation portal is documented by imaging procedure, all toxicities resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to treatment start. 5. Uncontrolled cardiac atrial or ventricular arrhythmias (New York Heart Association (NYHA) congestive heart failure = class 2; uncontrolled hypertension; pulmonary embolism or cerebrovascular accident (CVA) within 6 months 6. Neurologic: symptomatic motor or sensory neurotoxicity grade = 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC) 7. Central nervous system metastasis 8. Psychiatric disabilities, seizures or central nervous system disorders thought to be clinically significant in the opinion of the Investigator that could interfere with informed consent or compliance with the protocol 9. Active bleeding Grade = 2 of NCI-CTC 10. Serious (Grade 3-4 of NCI-CTC) active infections at time of treatment start 11. Subjects with known allergies or intolerance to RP101 or similar compounds 12. Subjects with known allergies or intolerance to gemcitabine 13. Participation in any investigational drug study with investigational drug exposure within 4 weeks prior to treatment start 14. Pregnant or breast feeding women 15. Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, such as uncontrolled inflammatory GI diseases (eg, Crohn’s disease, ulcerative colitis) or postsurgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency or requires IV hyperalimentation (however, use of pancreatic enzyme supplementation is allowed provided that the above criteria are not met) resulting in an inability to take oral medication 16. Known to be seropositive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis 17. Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study (eg, low medical risks because of non-malignant organ or systemic disease, or secondary effects of cancer) 18. Uncontrolled cancer pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinoma. ;Secondary Objective: - To compare progression-free survival (PFS) between the two treament arms - To compare the two treatment groups with respect to overall tumor response rates (ORR) which is the sum of the complete respone (CR) and partial response (PR) rates as assessed by the Response Evalulation Criteria in Solid Tumors (RECIST) in subjects with measurable disease at baseline - To compare the two treatment arms with respect to disease control rates (DCR) which is the sum of CR, PR and stable disease (SD) rates as assessed by RECIST in subjects with measurable disease at baseline - To compare the CR rates between the two treatment arms - To evaluate the CA 19-9 levels as a marker of disease response - To compare changes in ECOG performance status between the two treatment arms - To evaluate the safety of RP101 ;Primary end point(s): The primary efficacy endpoint will be overall survival defined as the time from randomization to death from any cause or last contact if alive | — |
Countries
Germany, Hungary, Netherlands, Spain
Outcome results
None listed