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

• Conditions: metastatic pancreatic cancer; MedDRA version: 9.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastatic; MedDRA version: 9.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectable

• Registration Number: EUCTR2007-004102-27-DE
• Lead Sponsor: SciClone Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-14
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 153

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
? Total bilirubin = 2.0 times the ULN for the institution
? ALT (SGPT) = 2.5 times the ULN and/or AST (SGOT) = 2.5 times the ULN for the institution. If clearly attributable to liver metastasis, ALT and/or AST = 5.0 times the ULN is permitted
If screening laboratory results are borderline and if the subject is otherwise eligible, a case by case discussion must take place between the PI and medical monitor. Approval from the medical monitor must be obtained for the patient to be included.
7. Capability of understanding the objectives of the Study and giving written informed consent
8. Willingness and ability to comply with the study protocol for the duration of the Study
9. Ability to have sufficient oral caloric and fluid intake and to take oral study medications
10. If subject is female and of child-bearing potential she must have a negative pregnancy test within 72 hours prior to receiving treatment. Being of child bearing potential is defined as any female subject who does not meet at least one of the following criteria: ( a ) Is surgically sterile; ( b ) Is older than 50 years of age and has not had a menstrual period for at least 24 months
11. All potentially fertile subjects, both female and male, must practice a medically approved method of contraception or agree to abstinence for the duration of participation in the active treatment phase of the Study and for a period of 28 days after the last administration of Study drug

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

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
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 28 days prior to treatment start
14. Pregnant or breast feeding women
15. Gastrointestinal (GI) tract disorders such resulting in an inability to take oral medication. These GI tract disorders include uncontrolled inflammatory GI diseases (e.g., Crohn’s disease, ulcerative colitis) or post-surgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency or requires IV hyperalimentation
16. Known to be seropositive for HIV, HBV, or HCV. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis
17. Other serious illness or medical condition that, in the opinion of the Investigator, would be expected to interfere with the subject’s ability to receive Study treatment or to comply with Study procedures
18. Uncontrolled cancer pain

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified