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Spots Global Cancer Trial Database for Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine

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Trial Identification

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

Official Title: Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine

Study ID: NCT01020006

Study Description

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.

Detailed Description: This study will be conducted in three segments: Part A, Part B and Part C. Parts A and B are 12 weeks of treatment followed by 4 weeks of evaluation. In part A patients will dose-escalate up to three dose levels of PCI-27483 administered as subcutaneous (SC) injections twice-daily (BID). Part B to start once 4th patient completes 90 of 112 doses in 8 weeks. In part B patients are randomized to PCI-27483 and gemcitabine (active arm) OR gemcitabine only (control arm). PCI-27483 doses in both Part A and B will be administered in combination with a standard regimen of gemcitabine. Patients with a tumor response or stable disease at 12 weeks will have the opportunity to continue PCI-27483 treatment until disease progression or the Investigator considers the study treatment to be no longer tolerable. Treatment with gemcitabine in either the active or control arm may continue until a standard course of gemcitabine therapy has been completed. Patients will complete Part A or Part B after 16 weeks on study regardless of treatment duration. Evaluable patients will roll over into part C and be followed for 12 months from enrollment (first dose).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, St. 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

Contact Details

Name: Eric Hedrick, MD

Affiliation: Pharmacyclics LLC.

Role: STUDY_DIRECTOR

Name: Laurence Elias, MD

Affiliation: Pharmacyclics LLC.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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