Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
1 other identifier
interventional
42
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pancreatic-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 20, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedResults Posted
Study results publicly available
April 2, 2014
CompletedApril 24, 2014
April 1, 2014
2.8 years
November 20, 2009
February 18, 2014
April 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (AEs)
Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0
First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).
Study Arms (2)
Gemcitabine
ACTIVE COMPARATORSubjects receive Gemcitabine 1000 mg/m2 weekly intravenous infusion.
PCI-27483 + Gemcitabine
EXPERIMENTALPart A: Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion. Part B: Subjects received the PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
Interventions
Part A: Closed to enrollment.Part B: Approximately 20 patients will be randomized to the control arm that will receive a standard regimen of gemcitabine and 20 patients will be randomized to the PCI-27483 arm and treated with both gemcitabine and PCI-27483. PCI-27483 will be administered as subcutaneous (SC) injections, nominally at a dosage of 1.2 mg/kg BID. Patients receiving PCI-27483 with a tumor response or stable disease at 12 weeks will have the option to continue PCI-27483 treatment until disease progression or the investigator considers the study treatment no longer tolerable. Treatment with gemcitabine may continue per standard of care. All evaluable patients will roll over into Part C at week 16 (Day 113±5). If 2 consecutive INRs at 2 hours postdose are \>3.50,a reduced dosage will be calculated.
Eligibility Criteria
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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
TGen Clinical Reserch Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Pacific Cancer Medical Center
Anaheim, California, 92081, United States
Space Coast Medical Associates
Titusville, Florida, 32796, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46260, United States
Kenthucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426, United States
Beth Israel Cancer Center
New York, New York, 10003, United States
Columbia University
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Summa Health System
Akron, Ohio, 44304, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414, United States
South Carolina Cancer Specialists, PA
Hilton Head, South Carolina, 29926, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37404, United States
Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Vermont/Vermont Cancer Center
Burlington, Vermont, 05401, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Laurence Elias
- Organization
- Pharmacyclics
Study Officials
- STUDY DIRECTOR
Eric Hedrick, MD
Pharmacyclics LLC.
- STUDY DIRECTOR
Laurence Elias, MD
Pharmacyclics LLC.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2009
First Posted
November 25, 2009
Study Start
November 1, 2009
Primary Completion
August 1, 2012
Last Updated
April 24, 2014
Results First Posted
April 2, 2014
Record last verified: 2014-04