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 - BAY 86-9766 in combination with gemcitabine in advanced pancreatic cancer

• Conditions: 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.; MedDRA version: 14.1Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-019588-12-CZ
• Lead Sponsor: Bayer HealthCare AG, Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-15
• Last Update Posted: 24 March 2014

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 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
• 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