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Gemcitabine

Antimetabolites

Subjects receive Gemcitabine 1000 mg/m2 weekly intravenous infusion.

Part 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.

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.

PCI-27483

Eric Hedrick, MD

Laurence Elias, MD

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.

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).

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

Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0

Pharmacyclics LLC.

Part A is a nonrandomized dose escalation arm. 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, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.

All treated subjects in this group experienced at least one "treatment-emergent" adverse event.

(PCI-27483 + Gemcitabine)/Part A

Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.

All treated subjects in this group experienced at least one "treatment-emergent" adverse event.

(PCI-27483 + Gemcitabine)/Part B

Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.

All treated subjects in this group experienced at least one "treatment-emergent" adverse event.

Gemcitabine/Part B

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Laurence Elias

Number of Participants With Treatment Emergent Adverse Events (AEs)

Part A is a nonrandomized dose escalation arm. 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 on 3 out of every 4 weeks.

PCI-27483 + Gemcitabine/Part A

Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.

PCI-27483 + Gemcitabine/Part B

Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine	NCT01020006	Pancreatic Canc... Ductal Adrenoca... Exocrine Pancre...	PCI-27483 Gemcitabine	18 Years -	Pharmacyclics LLC.
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine	NCT01020006	Pancreatic Canc... Ductal Adrenoca... Exocrine Pancre...	PCI-27483 Gemcitabine	18 Years -	Pharmacyclics LLC.

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