A Randomized, Double Blind, Placebo Controlled, Phase II Study Evaluating the Efficacy and Safety of RP101 in Combination with Gemcitabine Administered as First-Line Treatment to Subjects with Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma

SciClone Pharmaceuticals, Inc.0 sites153 target enrollmentFebruary 28, 2008

DrugsHelpin RP101 (BVDU)Gemzar

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: SciClone Pharmaceuticals, Inc.
Enrollment: 153
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 28, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

SciClone Pharmaceuticals, Inc.

Eligibility 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 \< 1\.5 times the upper limit of normal

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