Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine

Completed · Phase 2

Conditions studied: Pancreatic Cancer, Ductal Adrenocarcinoma, Exocrine Pancreatic Cancer

In brief

The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously administered gemcitabine for 12 weeks.

Key facts

Study ID

NCT01020006

Run by

Pharmacyclics LLC.

People needed

42

Starts

2009-11-01

Last updated by the study team

2014-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women at least 18 years old
• Body weight ≥ 40 and ≤ 100 kg.
• Part A: Metastatic ductal adenocarcinoma of the pancreas diagnosed ≤ 4 months prior to enrollment. (Locally advanced does not have any criteria)
• Part B: Locally advanced ductal adenocarcinoma of the pancreas diagnosed ≤ 3 months prior to enrollment or metastatic ductal adenocarcinoma diagnosed ≤ 2 months.
• Measurable disease by spiral CT scan (SCT) in accordance with RECIST criteria.
• Patients after non-curative surgery are eligible if at least 4 weeks after surgery and recovered from significant surgical morbidity.
• Estimated life expectancy of at least 4 months.
• ECOG performance status 0 to 1.
• Normal baseline coagulation function as defined by:
• PT 10-16 seconds, and
• aPTT 22-38 seconds.
• Agree to not participate in contact sports or strenuous activity while taking PCI-27483.
• Ability to understand the study, willingness to participate in the study for the study duration, and ability to provide written informed consent to participate.

You may not qualify if…

• History of any clinically significant medical condition that, in the opinion of the Principal Investigator, would interfere with the study evaluation or interpretation.
• Known history of brain metastases.
• Any evidence of intra-cranial hemorrhage based on head CT scan within 30 days of enrollment.
• History of disease progression while being treated with gemcitabine.
• Radiotherapy of the primary tumor or unwillingness to defer radiotherapy of the primary tumor until > 3 months from initiation of treatment.
• History of venous thromboembolism (eg, deep vein thrombosis, pulmonary embolism,and arterial thromboembolism) or other indications for anticoagulant treatment (eg,mechanical heart values, atrial fibrillation, etc.) within the last year. Local thrombus in the mesenteric or portal vein is acceptable.
• Uncontrolled hypertension (systolic > 160 or diastolic > 100 mm Hg on medical treatment).
• Continued anticoagulation therapy or anticoagulation therapy within 2 months prior to enrollment, except for perisurgical prophylaxis which must have ceased 2 weeks before enrollment.
• Contraindication to systemic anticoagulation.
• Continued treatment with antiplatelet drugs including aspirin, clopidogrel, etc. within the past 72 hours.
• Known history of clinically significant or recurrent bleeding episodes, including significant bleeding after surgery, childbirth, or dental extraction.
• Patients with documented invasion of adjacent organs by CT scan (e.g. stomach, duodenum) are not eligible
• Patients known to have esophageal varicose are not eligible
• Known history of a congenital coagulation factor deficiency.
• Known acquired or hereditary platelet disorder.
• Known history of immunodeficiency.
• Women of child-bearing potential or sexually active men, unwilling to use adequate contraceptive protection during the course of the study.
• Pregnant or lactating women (female patients of childbearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or if positive, pregnancy ruled out by ultrasound).
• Laboratory Abnormalities:
• Serum creatinine > 2 mg/dL or creatinine clearance < 50 mL/minute (using Cockroft Gault formula)
• AST and ALT ≥ 4.0 x upper limit of normal (ULN).
• Bilirubin ≥ 3 mg/dL.
• Alkaline phosphatase > 5 x ULN.
• Albumin < 2.0g/dL.
• Hemoglobin < 9.0 g/dL.

Where it is running

• TGen Clinical Reserch Services at Scottsdale Healthcare — Scottsdale, Arizona, United States
• Pacific Cancer Medical Center — Anaheim, California, United States
• Space Coast Medical Associates — Titusville, Florida, United States
• Investigative Clinical Research of Indiana — Indianapolis, Indiana, United States
• Kenthucky Cancer Clinic — Hazard, Kentucky, United States
• Park Nicollet Institute — Saint Louis Park, Minnesota, United States
• Beth Israel Cancer Center — New York, New York, United States
• Columbia University — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Summa Health System — Akron, Ohio, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States
• Charleston Hematology Oncology Associates — Charleston, South Carolina, United States
• South Carolina Cancer Specialists, PA — Hilton Head, South Carolina, United States
• Associates in Oncology and Hematology — Chattanooga, Tennessee, United States
• Sammons Cancer Center — Dallas, Texas, United States
• University of Vermont/Vermont Cancer Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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