fVIIa Inhibitor (PCYC-1001)

fVIIa Inhibitor Phase II Trial in Pancreatic Cancer -- PCYC-1001

Official Title

Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine, Part A

Purpose

The purpose of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered PCI-27483 at pharmacologically active doses during repeated, ascending dose administration to metastatic or locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously administered gemcitabine for 12 weeks. Secondly, to establish a dosage for evaluation in the Part B portion of this study.

Study Design

In Part A of this study, patients will dose-escalate up to three dose levels of PCI-27483 injected subcutaneously twice a day, in combination with a standard regimen of gemcitabine. This part consists of 12 weeks of treatment followed by 4 weeks of evaluation. Patients with a tumor response or stable disease at 12 weeks may continue treatment until disease progression or until a maximum tolerated dose is reached.

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 after 16 weeks on study regardless of treatment duration.

Eligibility

  • At least 18 years of age
  • Body weight greater than 40 kg and less than 90 kg
  • Body mass index (BMI) < 30.0 kg/m2
  • Locally advanced or metastatic ductal adenocarcinoma of the pancreas diagnosed ≤ 2 months
  • Less than two months of prior chemotherapy with gemcitabine
  • Disease measurable using both RECIST criteria and volume determination by spiral CT scan
  • Patients post non-curative surgery are eligible if at least 4 weeks post surgery and recovered from significant surgical morbidity
  • Estimated life expectancy of at least 4 months
  • ECOG performance status 0 to 1 

  • Normal baseline coagulation:

              1. PT 10-16 seconds and 2. aPTT 22-38 seconds
  • Refrain from participation in contact sports or strenuous activity while on trial
  • Willing and able to sign a written informed consent

For more details about this study, please refer to information posted at http://www.clinicaltrials.gov or contact Pharmacyclics Medical Affairs by email at MedicalAffairs@pcyc.com or 1.408.774.0330.