Study to investigate the novel drug BAY 86-9766 in combination with gemcitabine standard therapy in pancreatic cancer.

• Conditions: MedDRA version: 16.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; MedDRA version: 16.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; MedDRA version: 16.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; Pancreatic cancer is the eighth most common cause of cancer-related death worldwide, associated with a 5-year survival rate of 5-6%. A vast majority of patients present with incurable advanced disease. Untreated metastatic disease is associated with a median survival time of 3 to 5 months and locally advanced disease with 6-10 months.Gemcitabine is currently regarded as the standard therapy for locally advanced or metastatic pancreatic cancer.

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-07
• Last Update Posted: 24 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 93

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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

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
•History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
•Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR

Study & Design

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