None listed
Conditions
Interventions
Group 1 Type of group
RP101 will be administered 4 times a day as an oral tablet of 190 mg ios days 1-4, 8-11 and 15-18 of each cycle. Gemcitabine will be administered at a dose of 1,000 mg / m ^ on days 1, 8 and 15 of each 28-day cycle as an intravenous infusion of 30 minutes. When RP101 and gemcitabine are administered on the same day, the first tablet of RP101 will be administered one hour before gemcitabine.
Group name:Group 2 Type of group
They will receive gemcitabine tablets and placebo. The placebo will be administered 4 times a day on days 1-4, 8-11 and 15-18 of each cycle. Gemcitabine will be administered at a dose of 1,000 mg / m ^ on days 1, 8 and 15 of each cycle as an intravenous infusion of 30 minutes.
Sponsors
SciClone Pharmaceutical Inc.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Men or women of a minimum age of 18 years. • Patients with confirmed histological or cytological diagnosis of unresectable, locally advanced or metastatic pancreatic adenocarcinoma. • Functional status according to the ECOG scale of O or 1. • Life expectancy of at least 3 months. • Documentation of the extent of pancreatic cancer within 28 days prior to the start of treatment by MRI, CT, spiral CT of the thorax, abdomen, brain (only in case of clinical suspicion of metastasis) and other explorations as necessary. It is not necessary to repeat the negative scans performed during the 35-day period prior to randomization. • Adequate haematological, renal and hepatic function within 14 days prior to the start of treatment defined as: Hemoglobin> 9.0 gm / dl (prior transfusion and / or administration of erythropoietin-based products is considered acceptable). Absolute granulocyte count> 1.5 x 10 ^ / 1 (1,500 cells / mm3) without support of growth factors for 1 week. Platelet count> 100 x 10 6 / l (100,000 / mm3) and not dependent on platelet transfusions. Serum creatinine <1.5 times the upper limit of normal. Total bilirubin <2.0 times the upper normal limit. ALT (SGPT) <2.0 times the upper limit of normal and / or AST (SGOT) <2.0 times the upper limit of normal. In case it is evident that the values ​​are due to liver metastasis, ALT and / or AST <5 times the normal upper limit is allowed. • Patients with the ability to understand the objectives of the study and to grant written informed consent. • Patients with the will and ability to comply with the study protocol during the entire duration of the study. • Patients with adequate fluid intake and oral caloric intake and taking oral medications from the study. • If the patient is female and has a chance to conceive, a negative urine test result of P-HCG should be obtained within 72 hours of receiving the treatment. A woman with possibilities of conceiving is one who does not meet at least one of the following criteria: a) she has undergone a bilateral salpingo-oophorectomy and / or a hysterectomy; b) is over 50 years old and has not had a menstrual period for at least 24 months. • All potentially fertile patients, both women and men, must use a medically approved method of contraception or agree to abstain during their participation in the active treatment phase of the study and for a period of 4 weeks after the last administration of the medication. study.
Exclusion criteria
Exclusion criteria: • History of other malignant tumors, except non-melanoma skin cancer or in situ cervical carcinoma excised for curative purposes. The patient can be included if they have not had a cancer other than pancreatic cancer in the last 5 years. • Major surgery in the two weeks before the start of treatment. • Any prior cytotoxic chemotherapy other than 5-FU (+/- folic acid) or gemcitabine concurrently administered to radiation therapy as radiosensitizer. 5-FU should not be administered in the 21 days prior to randomization. • Radiotherapy within 4 weeks before the start of treatment. Prior radiotherapy is allowed for the management of localized disease, provided that localized disease progression or progression by new measurable metastasis flies from the radiation portal are documented by diagnostic imaging procedures, all toxicities are resolved and completed the last fraction of radiotherapy at least 4 weeks before the start of treatment. • Uncontrolled atrial or ventricular cardiac arrhythmia (cardiac failure of class II of the New York Heart Association, NYHA); uncontrolled hypertension, pulmonary embolism or CVA within 6 months. • Neurological: grade> 2 of symptomatic motor or sensory neurotoxicity according to the Common Toxicity Criteria of the National Cancer Institute (National Cancer Institute Common Toxicity Criteria [NCI-CTC]). • Metastasis of the central nervous system. • Psychiatric disability, convulsions or disorders of the central nervous system that, in the opinion of the investigator, are considered clinically significant and may interfere with informed consent or compliance with the protocol. • Degree of active bleeding> 2 of NCI-CTC • Severe active infection (grade 3-4 of NCI-CTC) at the time of treatment initiation. • Patients with known allergy or intolerance to RPIOI or similar components. • Patients with known allergy or intolerance to gemcitabine. • Participation in any study of an experimental drug with exposure to the experimental drug in the 4 weeks prior to the start of treatment. • Pregnancy or breastfeeding. • Gastrointestinal tract (OI) disorders that make it impossible to take oral medication, such as uncontrolled inflammatory GI disorders (eg, Crohn´s disease, ulcerative colitis) or post-surgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and a deficiency of vitamins or that requires IV hyperalimentation (however, the use of pancreatic enzyme supplements is allowed provided that the criteria described above are not met) and that the intake of oral medication is impossible. • known HIV, HBV or HCV positive. It is not necessary to carry out analyzes in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis. • Any disorder that, in the investigator´s judgment, could pose a risk to the patient or that could interfere with the results of the study (eg, low medical risk due to non-malignant systemic or organic disorder, or cancer side effects). • Cancerous pain not controlled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time from randomization to death for any cause or the last contact if still alive. Measure:Overall Survival Timepoints:After the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Determined as the time from randomization to the first observation of disease progression or death from any cause or the last evaluation of the tumor in case of progression-free. Measure:Progression Free Survival (PFS) Timepoints:After the study ; Outcome name:Defined as the sum of: complete response (CR) and partial response (PR) . Measure:Overall response rate (ORR) Timepoints:During the study ; Outcome name:Defined as the sum of GR, PR and SD (stable disease index). Measure:Disease control rate Timepoints:During the study ; Outcome name:Determined as the time from meeting the criteria for CR / PR / SD until the first date of recurrent or progressive illness or death. Measure:Duration of response Timepoints:until the first date of recurrent or progressive illness or death. ; Outcome name:Measurement of CA19-9 levels measured on day 1 of each treatment cycle, EOT and one month follow-up after EOT. Measure:Longitudinal changes in CA 19-9 levels Timepoints:On day 1 of each treatment cycle, EOT and one month follow-up after EOT. | — |
Countries
Argentina, Brazil, Chile, France, Germany, Hungary, Netherlands, Peru, Poland, Romania, Spain, United Kindgdom, United States
Outcome results
None listed