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Clinical Trials/EUCTR2007-004102-27-DE
EUCTR2007-004102-27-DE
Active, not recruiting
Not Applicable

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 enrollmentMarch 14, 2008
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Conditionsmetastatic pancreatic cancerMedDRA version: 9.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectable
DrugsGemzar

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
metastatic pancreatic cancer
Sponsor
SciClone Pharmaceuticals, Inc.
Enrollment
153
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 14, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female subjects 18 years of age and 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 within 28 days prior to randomization, by MRI or CT or spiral CT scan of chest, abdomen, pelvis, brain (only if clinical suspicion of metastasis), and other scans as necessary
  • •6\. Adequate hematological, renal, and hepatic function within 14 days prior to treatment start defined as follows:
  • •? Hemoglobin \= 9\.0 g/dL. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level for inclusion is not allowed
  • •? Absolute neutrophil count (ANC) \= 1\.5 x 109/L unsupported for 1 week by growth factors
  • •? Platelet count \= 100 x 109/L and non\-platelet transfusion dependent
  • •? Serum creatinine concentration \= 1\.5 times the upper limit of normal (ULN) for the institution

Exclusion Criteria

  • •1\. Prior chemotherapy or radiation therapy for locally advanced and unresectable or metastatic pancreatic cancer
  • •2\. 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 at least 5 years
  • •3\. Major surgery within 14 days prior to Study entry
  • •4\. 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 28 days 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\. Active bleeding Grade \= 2 of NCI\-CTC
  • •9\. Psychiatric disabilities, seizures or central nervous system disorders thought to be clinically significant that, in the opinion of the Investigator, could interfere with informed consent or compliance with the protocol
  • •10\. Grade 3\-4 of NCI\-CTC active infections at time of treatment start

Outcomes

Primary Outcomes

Not specified

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