A multi-center, phase I/II study of BAY 86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer - ND

• Conditions: on-resectable, locally advanced or metastatic Pancreatic Cancer; MedDRA version: 13.1Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-019588-12-IT
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-10
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Male or female patients =18 years of age • Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery • Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1 • Resolution of all acute toxic effects of any prior local treatment to CTCAE Grade = 1 • Eastern Cooperative Oncology Group performance status (ECOG PS) = 2 • Patient has cardiac function, within normal range, as measured by an echocardiogram
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

>• Known history of, or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease). • History of cardiac disease - Congestive heart failure New York Heart Association (NYHA) = Class 2; - Unstable angina (angina symptoms at rest, new-onset angina, ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months prior to start of study treatment - Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), or uncontrolled hypertension, (systolic blood pressure [BP] >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management). • Active clinically serious infections (> Grade 2) •Clinically significant (ie, symptomatic) peripheral vascular disease Pregnant or lactating women; women of childbearing potential not employing adequate contraception. • Use of strong inhibitors of CYP3A4, (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir), and strong inducers of CYP3A4 (eg, rifampin) • Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignant conditions including cytotoxic chemotherapy, targeted agents, or any experimental therapy • Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment •Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of study treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the efficacy of the combination BAY 86-9766 / gemcitabine in terms of the overall response rate (confirmed complete response + partial response) according to RECIST Version 1.1;Secondary Objective: •Response duration (DOR) •Disease control rate (DCR) •Time to progression (TTP) •Progression-free survival (PFS) •Overall survival (OS) •Asses safety and tolerability profile of the combination drug therapy •Determine patient reported outcome (pain evaluation) •Assess biomarkers;Primary end point(s): Overall response rate (confirmed complete response + partial response) according to RECIST Version 1.1